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September 24, 2009 Nicole Lurie, M.D., M.S.P.H. Assistant Secretary for Preparedness and Response Office of the Assistant Secretary for Preparedness and Response Department of Health and Human Services 200 Independence Ave., S.W. Washington, DC 20201 Dear Dr. Lurie: On behalf of the Institute of Medicine (IOM) Committee on Guid- ance for Establishing Standards of Care for Use in Disaster Situations, we are pleased to report our conclusions and recommendations. At the request of the Office of the Assistant Secretary for Preparedness and Re- sponse, Department of Health and Human Services, the IOM convened this committee to develop guidance that state and local public health of- ficials and health-sector agencies and institutions can use to establish and implement standards of care that should apply in disaster situationsâ both naturally occurring and manmadeâunder scarce resource condi- tions. Specifically, the committee was asked to identify and describe the key elements that should be included in standards of care protocols, to identify potential triggers, and to develop a template matrix that can be used by state and local public health officials as a framework for devel- oping specific guidance for healthcare provider communities to develop crisis standards of care. The committee was asked to consider the roles and responsibilities of various stakeholders in the implementation of the guidance, and to consider mechanisms for integrating the views of the general public and healthcare providers in the development and imple- mentation of the guidance. The committee was also specifically charged with incorporating ethical principles into the guidance. To accomplish its charge within the accelerated time frame, the committee held a 4-day meeting that included a 1-day workshop. Panel discussions at the workshop focused on federal and state efforts associ- 1
2 CRISIS STANDARDS OF CARE GUIDANCE ated with establishing standards of care; guidance on standards of care in medical triage events; changing roles and responsibilities of healthcare workers under contingency and crisis standards of care; guidance on le- gal, ethical, and practical issues in setting standards of care in declared emergencies; and identifying triggers. The committee does seek to make clear that the extraordinary time constraints significantly limited the op- portunity to consider more evidence and enlist other stakeholders in the deliberations process. This is particularly true given the complexity and importance of the issues being considered. This letter serves as a sum- mary of the committeeâs conclusions and recommendations. Greater de- tail can be found in the relevant report text that follows this letter. Through a careful review of available protocols, the committee rec- ognizes that although some federal, state, municipality, territorial, and health-sector agencies and institutions have made considerable progress in developing protocols, many states have only just begun to address this urgent need. Furthermore, there is a need to develop all protocols around the same key elements and components to ensure coordination, consis- tency, and fair allocation of scarce resources during a disaster. In the development of its national guidance on standards of care, the committee was asked to consider if there should be a single national guidance or scenario-specific guidance. Based on a review of the cur- rently available state standards of care protocols, published literature, and testimony provided at its workshop, the committee concluded that there is an urgent and clear need for a single national guidance for states for crisis standards of care that can be generalized to all crisis events and is not specific to a certain event. However, the committee recognizes that within the single general framework, individual disaster scenarios may require specific considerations, such as differences between no-notice events versus slow-onset events, but that the key elements and compo- nents remain the same. The committee was tasked to develop national framework guidance on the key elements that should be included in standards of care proto- cols for disaster situations. Ethical norms in medical care do not change during disasters â health care professionals are always obligated to pro- vide the best care they reasonably can under given circumstances. For purposes of developing recommendations for situations when healthcare resources are overwhelmed, the committee defines the level of health and medical care capable of being delivered during a catastrophic event as crisis standards of care.
LETTER REPORT 3 âCrisis standards of careâ is defined as a substantial change in usual healthcare operations and the level of care it is possible to deliver, which is made necessary by a pervasive (e.g., pandemic influenza) or catastrophic (e.g., earthquake, hurricane) disaster. This change in the level of care delivered is justified by specific circum- stances and is formally declared by a state government, in recognition that crisis operations will be in effect for a sustained period. The formal declaration that crisis stan- dards of care are in operation enables specific le- gal/regulatory powers and protections for healthcare providers in the necessary tasks of allocating and using scarce medical resources and implementing alternate care facility operations. To ensure that the utmost care possible is provided to patients in a catastrophic event, the nation needs a robust system to guide the public, healthcare professionals and institutions, and governmental entities at all levels. To achieve such a system of just care, the committee sets forth the following vision for crisis standards of care: â¢ Fairnessâstandards that are, to the highest degree possible, rec- ognized as fair by all those affected by them â including the members of affected communities, practitioners, and provider organizations, evidence based and responsive to specific needs of individuals and the population focused on a duty of compas- sion and care, a duty to steward resources, and a goal of main- taining the trust of patients and the community â¢ Equitable processesâprocesses and procedures for ensuring that decisions and implementation of standards are made equitably o Transparencyâin design and decision making o Consistencyâin application across populations and among individuals regardless of their human condition (e.g., race, age, disability, ethnicity, ability to pay, socioeconomic status, preexisting health conditions, social worth, perceived obstacles to treatment, past use of resources) o Proportionalityâpublic and individual requirements must be commensurate with the scale of the emergency and degree of scarce resources
4 CRISIS STANDARDS OF CARE GUIDANCE o Accountabilityâof individuals deciding and implementing standards, and of governments for ensuring appropriate pro- tections and just allocation of available resources â¢ Community and provider engagement, education, and communi- cationâactive collaboration with the public and stakeholders for their input is essential through formalized processes â¢ The rule of law o Authorityâto empower necessary and appropriate actions and interventions in response to emergencies o Environmentâto facilitate implementation through laws that support standards and create appropriate incentives Throughout the report the committee emphasizes the need for states to develop and implement consistent crisis standards of care protocols both within the state and through work with neighboring states, in col- laboration with their partners in the public and private sectors. This re- port contains guidance to assist state public health authorities in developing these crisis standards of care. This guidance includes criteria for determining when crisis standards of care should be implemented, key elements that should be included in the crisis standards of care pro- tocols, and criteria for determining when these standards of care should be implemented. With the intent of assisting the many states that are still in the early stages of developing crisis standards of care, the committee lays out a broad process for developing crisis standards of care protocols that en- compasses the full spectrum of the health system, including emergency medical services and dispatch, public health, hospital-based care, home care, primary care, palliative care, mental health, and public health. Fur- thermore, although the compressed time frame limited the scope of the work presented here and the opportunity for a robust community- engagement process, the committee strongly recommends extensive en- gagement with community and provider stakeholders. Such public en- gagement is necessary not only to ensure the legitimacy of the process and standards, but more importantly to achieve the best possible result. Recommendation: Develop Consistent State Crisis Standards of Care Protocols with Five Key Elements State departments of health, and other relevant state agencies, in partnership with localities should de- velop crisis standards of care protocols that include
LETTER REPORT 5 the key elementsâand associated componentsâ detailed in this report: â¢ A strong ethical grounding; â¢ Integrated and ongoing community and pro- vider engagement, education, and communi- cation; â¢ Assurances regarding legal authority and en- vironment; â¢ Clear indicators, triggers, and lines of re- sponsibility; and â¢ Evidence-based clinical processes and opera- tions. Recommendation: Seek Community and Provider Engagement State, local, and tribal governments should partner with and work to ensure strong public engagement of community and provider stakeholders, with particu- lar attention given to the needs of vulnerable popula- tions and those with medical special needs, in: â¢ Developing and refining crisis standards of care protocols and implementation guidance; â¢ Creating and disseminating educational tools and messages to both the public and health professionals; â¢ Developing and implementing crisis commu- nication strategies; â¢ Developing and implementing community re- silience strategies; and â¢ Learning from and improving crisis stan- dards of care response situations. An ethical framework serves as the bedrock for public policy and cannot be added as an afterthought. Hence, ethical principles underlie the committeeâs vision for crisis planning, outlined above. In addition, ethi- cally and clinically sound planning will aim to secure fair and equitable resources and protections for vulnerable groups. The committee con- cluded that core ethical precepts in medicine permit some actions during
6 CRISIS STANDARDS OF CARE GUIDANCE crisis situations that would not be acceptable under ordinary circum- stances, such as implementing resource allocation protocols that could preclude the use of certain resources on some patients when others would derive greater benefit from them. But even here, it is the situation that changes during disasters, not ethical standards per se. The context of a disaster may make certain resources unavailable for some or even all pa- tients, but it does not provide license to act without regard to professional or legal standards. Healthcare professionals are obligated always to pro- vide the best care they reasonably can to each patient in their care, in- cluding during crises. When resource scarcity reaches catastrophic levels, clinicians are ethically justified â and indeed are ethically obligated â to use the available resources to sustain life and well-being to the greatest extent possible. As a result, the committee concluded that ethics permits clinicians to allocate scarce resources so as to provide necessary and available treatments preferentially to those patients most likely to benefit when operating under crisis standards of care. However, operating under crisis standards of care does not permit clinicians to ignore professional norms nor to act without ethical standards or accountability. Recommendation: Adhere to Ethical Norms During Crisis Standards of Care When crisis standards of care prevail, as when ordi- nary standards are in effect, healthcare practitioners must adhere to ethical norms. Conditions of over- whelming scarcity limit autonomous choices for both patients and practitioners regarding the allocation of scarce healthcare resources, but do not permit ac- tions that violate ethical norms. The committee also addressed issues related to the implementation of standards of care, including legal considerations. Questions of legal em- powerment of various actions to protect individual and communal health are pervasive and complicated by interjurisdictional inconsistencies. The law should clarify prevailing standards of care and create incentives for actors to respond to protect the publicâs health and respect individual rights.
LETTER REPORT 7 Recommendation: Provide Necessary Legal Protec- tions for Healthcare Practitioners and Institutions Implementing Crisis Standards of Care In disaster situations, tribal or state governments should authorize appropriate agencies to institute crisis standards of care in affected areas, adjust scopes of practice for licensed or certified healthcare practitioners, and alter licensure and credentialing practices as needed in declared emergencies to create incentives to provide care needed for the health of individuals and the public. Finally, and continuing the theme of consistency, the committee highlighted operational issues to ensure the consistent implementation of the crisis standards of care in a disaster situation within and among states. Recommendation: Ensure Consistency in Crisis Standards of Care Implementation State departments of health, and other relevant state agencies, in partnership with localities should ensure consistent implementation of crisis standards of care in response to a disaster event. These efforts should include: â¢ Using âclinical care committees,â âtriage teams,â and a state-level âdisaster medical advisory committeeâ that will evaluate evi- dence-based, peer-reviewed critical care and other decision tools and recommend and im- plement decision-making algorithms to be used when specific life-sustaining resources become scarce; â¢ Providing palliative care services for all pa- tients, including the provision of comfort, compassion, and maintenance of dignity; â¢ Mobilizing mental health resources to help communitiesâand providers themselvesâto manage the effects of crisis standards of care
8 CRISIS STANDARDS OF CARE GUIDANCE by following a concept of operations devel- oped for disasters; â¢ Developing specific response measures for vulnerable populations and those with medi- cal special needs, including pediatrics, geriat- rics, and persons with disabilities; and â¢ Implementing robust situational awareness capabilities to allow for real-time information sharing across affected communities and with the âdisaster medical advisory committee.â Recommendation: Ensure Intrastate and Interstate Consistency Among Neighboring Jurisdictions States, in partnership with the federal government, tribes, and localities, should initiate communications and develop processes to ensure intrastate and inter- state consistency in the implementation of crisis stan- dards of care. Specific efforts are needed to ensure that the Department of Defense, Veterans Health Administration, and Indian Health Services medical facilities are integrated into planning and response efforts. The guidance outlined here is intended to assist federal, tribal, state, and local officials in the development of more uniform crisis standards of care policies and protocols that are applicable in any disaster impacting the publicâs health. Applying the guidance and principles laid out in the report, the committee developed two brief case studies that may serve to illustrate the implementation crisis standards of care. Recognizing the current attention and concern surrounding the 2009 H1N1 pandemic, one scenario focuses on a gradual-onset influenza pandemic modeled around potential issues that may arise this fall during the current pandemic. The second scenario focuses on an earthquake as a model for discussion of the issues that would arise due to a no-notice sudden onset event. The committeeâs intent is to provide a framework that allows consis- tency in establishing the key components required of any effort focused on crisis standards of care in a disaster situation. It also intends that by suggesting a uniform approach, consistency will develop across geo- graphic and political boundaries so that this guidance will be useful in
LETTER REPORT 9 contributing to a single, national framework for responding to crisis in a fair, equitable, and transparent manner. The committee appreciates the opportunity to begin to lay the foun- dation for this important two-phase project as well as the opportunity to help the nation prepare not only for the upcoming pandemic, but for all disaster scenarios where the health system may be stressed to its limits. We look forward to undertaking the second phase of this project, in which the committee will expand stakeholder and public engagement efforts, as well as update and expand the guidance based on input and feedback from individuals and groups involved in the development and implementation of crisis standards of care. Lawrence O. Gostin, J.D., Chair Dan Hanfling, M.D., Vice Chair Committee on Guidance for Establishing Standards of Care for Use in Disaster Situations
10 CRISIS STANDARDS OF CARE GUIDANCE BACKGROUND The current influenza pandemic caused by the 2009 H1N1 virus un- derscores the immediate and critical need to prepare for a public health emergency in which thousands, tens of thousands, or even hundreds of thousands of people suddenly seek and require medical care in communi- ties across the United States. Although this may occur over hours, days, or weeks, this overwhelming surge on the healthcare system will dra- matically strain medical resources and could compromise the ability of healthcare professionals to adhere to normal treatment procedures and conventional standards of care. The Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), charged the Institute of Medicine committee responsible for this study with the task of developing guidance to establish standards of care that should apply to disaster situationsâboth naturally occurring and manmadeâunder conditions in which resources are scarce (Box 1). The Committee on Guidance for Establishing Standards of Care for Use in Disaster Situations brings together a broad spectrum of expertise, including state and local public health, emergency medicine and re- sponse, primary care, nursing, palliative care, ethics, the law, behavioral health, and risk communication (Appendix E). This letter report is not intended to obviate or substitute for extensive additional consideration and study of this complex issue, but is focused on articulating current concepts and preliminary guidance that can assist state and local public health officials, healthcare facilities, and professionals in the develop- ment of systematic and comprehensive policies and protocols for stan- dards of care in disasters where resources are scarce. These policies and protocols must conform to rigorous standards of science, law, and ethics. The committee focused its efforts on establishing a framework for the development and implementation of standards of care and associated triggers during disaster events. It was not responsible for establishing, creating, or defining what should be such crisis standards of care and associated triggers. This guidance is intended to assist federal policy makers and state and local officials in the development of more extensive and nation- ally/regionally consistent crisis standards of care policies and protocols that are applicable to all disaster situations. The committee developed
LETTER REPORT 11 BOX 1 Statement of Task In response to a request from the Department of Health and Human Ser- vicesâ Office of the Assistant Secretary for Preparedness and Response (ASPR), the Institute of Medicine (IOM) will convene an ad hoc committee to conduct a two-phase activity on standards of care for use in disaster situations. The committee will focus attention on developing guidance to establish stan- dards of care that should apply to disaster situationsâboth naturally occurring and manmadeâwhere resources are scarce. Ethical principles will be incorpo- rated into the standards. Phase 1 An ad hoc committee of the IOM will conduct a study and issue a letter re- port to the ASPR by October 1, 2009. The letter report will provide guidance on standards of care for use in disaster situations. Specifically, the committee will: â¢ Develop preliminary framework guidance that identifies and describes the key elements that should be included in disaster standards of care protocols; â¢ Identify potential triggers that can be used by state and local public health officials to develop standards of care protocols that will assist healthcare providers; â¢ Develop a template matrix that can be used by state and local public health officials as a framework for developing specific guidance for healthcare providers to develop disaster standards of care; â¢ Consider roles and responsibilities of various stakeholders in the im- plementation of the guidance; and â¢ Consider mechanisms for integrating the views of the general public and healthcare providers in the development and implementation of the guidance. The letter report will identify triggers that indicate a need to change from nor- mal standards to disaster standards. Disaster standards will consider ap- proaches to conserving, substituting, adapting. and doing without resources. The committee will not be responsible for establishing, creating, or defining standards of care. The committee will also commission a paper to be delivered by Septem- ber 1, 2009. This commissioned paper will provide background to the commit- tee deliberations and will examine the key elements in existing state and local standards of care protocols and the impact of allocation schemes on disaster standards, and propose framework guidance for national disaster standards that can be applied to nH1N1 response for the coming fall flu season. In addi- tion, the commissioned paper will explore issues related to the implementation of standards of care protocols, including legal considerations. The committee will base its recommendations on currently available policies, protocols, pub- lished literature, and other available guidance documents and evidence, as well as its expert judgment.
12 CRISIS STANDARDS OF CARE GUIDANCE Phase 2 Phase 2 of the project will prepare a report that will update the preliminary guidance developed in phase 1. The expanded guidance will be based on a se- ries of stakeholder input activities. During this phase the committee will seek in- put and comment from individuals who used the guidance developed in phase I. In addition, the committee will organize and host a series of data-gathering activi- ties focused on the provider community and the public (e.g., local civic organiza- tions, leaders from faith-based groups, educators) that would allow an opportunity to provide comment on the guidance developed in phase 1. The expanded report will include considerations about triggers that apply to changes in the standards of care and approaches to conserving, substituting, adapting, and doing without resources. In addition, the committee will develop guidance that will include in- formation for healthcare providers from primary care, home health, community health centers, and other provider communities not traditionally engaged. two case studies that illustrate the application of the guidance and princi- ples laid out in the report to two different scenarios (Appendix C). Rec- ognizing the current attention and concern around the 2009 H1N1 pandemic, one scenario focuses on a gradual-onset pandemic flu, mod- eled around issues that may arise this upcoming flu season. The other scenario focuses on an earthquake and the particular issues that would arise during a no-notice event. 2009 H1N1 Influenza Pandemic and Other Public Health Emergencies and Disasters Although there is still significant uncertainty about the likely severity and extent of the 2009 H1N1 influenza outbreak in the fall, there is great concern that demand for healthcare services could increase dramatically, resulting in a severe strain on medical resources across the United States. Mexico reported the first case of the novel virus nH1N1 on April 12, 2009, and by June 11 the World Health Organization (WHO) raised its pandemic alert level to a full-blown pandemic. Within 9 weeks of the first reported cases, every WHO region reported cases, and now the virus has spanned the globe, affecting more than 170 countries (WHO, 2009). The virus spread throughout most of the southern hemisphere during that regionâs winter influenza season, while continuing to circulate in the summer months in the northern hemisphere. In the United States, 9,079 hospitalizations and 593 deaths associated with 2009 H1N1 were reported to the Centers for Disease Control and Prevention (CDC) as of August 30, 2009 (CDC, 2009a). During the peak
LETTER REPORT 13 U.S. influenza season, multiple viral strains may be circulating simulta- neouslyâ2009 H1N1 and seasonal influenza. Over the past few years, in anticipation of a severe pandemic of H5N1 (âbird fluâ) and other public health emergencies (e.g., bioterrorism), many states and healthcare insti- tutions have been developing pandemic and other emergency prepared- ness plans that include enhancing healthcare system surge capacity to respond to catastrophic and mass casualty events. Government agencies and the healthcare system are now heavily preparing for the possibility of needing to implement their pandemic plans (or revised versions of them to reflect the current severity of the H1N1 pandemic) during the upcom- ing influenza season, even though at present 2009 H1N1 has not been highly pathogenic. Although the 2009 H1N1 pandemic is currently receiving the highest attention in the medical and public health community, the nation also faces the possibility of many other potential public health emergencies and disasters that could severely strain medical resources. For example, the detonation of an improvised nuclear device in a large city would cause massive numbers of injured and dead (IOM, 2009a). Similarly, other disasters caused by terrorism or by natural causes, such as fires, floods, earthquakes, and hurricanes, have the potential to overwhelm the medical and public health systems. Scarce Resources, Demand for Healthcare Services, and Standards of Care In preparation for response to any large-scale disaster or public health emergency, healthcare facilities are developing surge plans that include efforts to increase and maximize use of available resources, as well as to manage demand for healthcare services. Facilities can use re- source-sharing agreements (e.g., mutual aid agreements) and other mechanisms that enable full use of the communityâs resources, which should include the regional resources and capabilities of the health sys- tems of the Veterans Administration, the Department of Defense (DoD), and Indian Health Services. Communities may also request resource sup- port from state and federal disaster supply caches, including those of the Strategic National Stockpile. However, in the setting of an influenza pandemic, where the shortage of resources is likely to occur on a national scale, the availability of such supplementary support is much less certain. Beyond preparedness stocking, facilities can also implement a variety of
14 CRISIS STANDARDS OF CARE GUIDANCE strategies that permit conservation, reuse, adaptation, and substitution for certain resources, doing so in a way that minimizes the impact on clinical care (Rubinson et al., 2008b; Rubinson et al., 2008a; Minnesota Depart- ment of Health, August 2008). To manage demand, surge plans may also include the use of an alternate care system that allows for the delivery of healthcare services along a stratified spectrum which includes home health care, community-based care, and the use of alternate care facilities (Hick et al., 2004; Kaji et al., 2006; Barbisch and Koenig, 2006; Davis et al., 2005; Hanfling, 2006; California Department of Public Health, 2008; Kelen et al., 2009). However, these measures may not always be sufficient, especially in a wide-reaching public health emergency or disaster in which resources are simultaneously strained in communities across the nation. Faced with severe shortages of equipment, supplies, and pharmaceuticals, an insuffi- cient number of qualified healthcare providers, overwhelming demand for services, and a lack of suitable space, healthcare practitioners will have to make difficult decisions about how to allocate these limited re- sources if contingency plans do not accommodate incident demands. Un- der these circumstances, it may be impossible to provide care according to the conventional standards of care used in non-disaster situations, and, under the most extreme circumstances, it may not even be possible to provide the most basic life-sustaining interventions to all patients who need them. The impact of these circumstances will likely carry a tremen- dous social cost on the healthcare workforce and the nation as a whole. An important consideration regarding the framework for the imple- mentation of crisis standards of care in a disaster includes the recognition that it will never be an âall or noneâ situation. Disasters will have vary- ing impacts on communities, based on many different variables that might affect the delivery of health care during such events. Response to a surge in demand for healthcare services will likely fall along a contin- uum ranging from âconventionalâ to âcontingencyâ and âcrisisâ surge responses (Hick et al., 2009). Conventional patient care uses usual resources to deliver health and medical care that conforms to the expected standards of care of the community. The delivery of care in the setting of contingency surge re- sponse seeks to provide patient care that remains functionally equivalent to conventional care. Contingency care adapts available patient care spaces, staff, and supplies as part of the response to a surge in demand for services. Although this may introduce minor risk to the patient com- pared to usual care (e.g., substituting less familiar medications for those
LETTER REPORT 15 in short supply, thereby potentially leading to medication dosage error), the overall delivery of care remains mostly consistent with community standards. Crisis care, however, occurs under conditions in which usual safeguards are no longer possible. Crisis care is provided when available resources are insufficient to meet usual care standards, thus providing a transition point to implementing crisis standards of care. Note that in an important ethical sense, entering a crisis standard of care mode is not optional â it is a forced choice, based on the emerging situation. Under such circumstances, failing to make substantive adjustments to care op- erations â i.e., not to adopt crisis standards of care â is very likely to re- sult in greater death, injury or illness. The goal for the health system is to increase the ability to stay in conventional and contingency categories through preparedness and anticipation of resource needs prior to serious shortages, and to return as quickly as possible from crisis back across the continuum to conventional care. Recognizing that such a spectrum exists may help communities iden- tify where they are along this continuum, provide a uniform and consis- tent way to evaluate and report surge conditions, and illustrate the spectrum of adaptations required to address the situation. State and Local Policies and Protocols The issue of crisis standards of care for use in disaster situations in- volving scarce resources arose largely since 2004, when the Agency for Healthcare Research and Quality (AHRQ) and the ASPR within HHS convened a meeting of experts. Drawn from the fields of bioethics, emergency medicine, emergency management, health administration, law and policy, and public health, experts engaged in groundbreaking discussions and confronted these issues directly. Their deliberations led to a report, Altered Standards of Care in Mass Casualty Events (AHRQ, 2005b), which laid out major concerns and areas that require considera- tion and recommended next steps for future action. A subsequent report, Mass Medical Care with Scarce Resources: A Community Planning Guide, laid down the framework for much of the current planning efforts (Phillips and Knebel, 2007). Since the release of the 2005 AHRQ report, many federal, state, and local efforts to develop protocols for the allocation of scarce resources and for standards of care have occurred. Nevertheless, a recent report on state preparedness by the U.S. Government Accountability Office (GAO)
16 CRISIS STANDARDS OF CARE GUIDANCE and a recent review of HHSâs Hospital Preparedness Program by the Center for Biosecurity of UPMC concluded that among the key compo- nents of medical surge planning, âstandards of care during a mass casu- alty eventâ remained in need of significant additional attention and planning (GAO, June 2008; Toner et al., 2009). Areas of particular con- cern cited were the need for states to develop protocols for implementing standards of care in disaster situations and the need to achieve a higher level of consistency across neighboring jurisdictions. Federal policy makers and state and local officials, in consultation with stakeholders from the private healthcare sector, could use the results of this committeeâs work to inform the development of more extensive and nationally/regionally consistent standards of care policies and proto- cols. METHODS To conduct this expert assessment and develop guidance for estab- lishing standards of care for use in disasters, the committee met from September 1 to 4, 2009. The meeting included a day-long public work- shop (see Appendix D). The purpose of the workshop was to hear from the public and experts with a wide breadth of experience and perspec- tives on this topic. In addition, the committee also heard from relevant stakeholder organizations, including federal agencies and representatives from key components of the public health system and healthcare system, to inform the committee about relevant ongoing and planned initiatives. Finally, the committee commissioned a white paper by Dr. Jeffrey Dichter and Dr. Michael Christian that provided a broad overview of many of the currently available standards of care protocols. Throughout the report terms such as âcrisis standards of careâ or âtriage teamâ have been used. Recognizing potential confusion, the committee developed a glossary to define the reportâs key terms (Appendix B). Additional background and context for the committeeâs work was provided by a series of four regional meetings held in the spring of 2009 by the Institute of Medicineâs Forum on Medical and Public Health Pre- paredness for Catastrophic Events. These regional meetings on Standards of Care During Mass Casualty Events were designed to describe and demonstrate the current regional, state, and local efforts to establish dis- aster standards of care policies, and to improve regional efforts by facili- tating dialogue and coordination among neighboring jurisdictions.
LETTER REPORT 17 During these meetings, many state and local officials identified the need for national guidance on standards of care for disaster situations as a cru- cial area for improving the nationâs preparedness (IOM, 2009c). The committee performed a limited literature review that included more than 200 references. In addition, the committee specifically reviewed a num- ber of available standards of care protocols from states and other gov- ernment agencies (Veterans Health Administration or VHA; the states of California, Colorado, Massachusetts, Minnesota, New York, Utah, Vir- ginia, and Washington; and the Canadian province of Ontario). This letter report is based on the committeeâs expert judgment and assessment of the currently available policies and protocols, published literature and other available guidance documents and evidence, and the workshop presentations and discussions. The compressed schedule lim- ited the scope of work presented here, but most importantly, it greatly limited the committeeâs ability to perform an extensive engagement with community and provider stakeholders. However, phase 2 will allow the committee to carry out a more deliberative project that will specifically include expanded stakeholder and public engagement efforts. It will also provide an opportunity to update and expand the crisis standards of care guidance based on input and feedback from individuals involved in the development and implementation of crisis standards of care. CRISIS STANDARDS OF CARE: THE VISION The U.S. health system affords many Americans a high quality of health care. Existing levels of health care in routine situations in the United States are unlikely to be available in times of a mass disaster in- volving scarce resources. Therefore, the United States must continue to plan for a catastrophic public health event that will cause grave injury, disease, or death to potentially thousands or tens or hundreds of thou- sands in a city, region, or entire nation. Public health emergencies such as a novel infectious disease (e.g., 2009 H1N1 or severe acute respiratory syndrome [SARS]), an intentional release of a biological agent (e.g., an- thrax or smallpox), or a weather or climatic event (e.g., hurricane or tor- nado) highlight the ever-changing threats posed by naturally occurring and intentional threats to the publicâs health. To plan for a catastrophic event, the nation needs to prepare consci- entiously and systematically to ensure that (1) the response offers the best care possible given the resources at hand; (2) decisions are fair and
18 CRISIS STANDARDS OF CARE GUIDANCE transparent; (3) policies and protocols within and across states are consis- tent; and (4) citizens and stakeholders are included and heard. Laws and the legal environment must support response efforts and create incentives for healthcare practitioners to care for affected populations. Although the usual high quality of health services cannot be assured during a catastro- phic event, the nation must do all it can to gain the trust of the public by responding fairly and effectively, particularly for vulnerable persons (Gostin and Powers, 2006). The committee was tasked to develop national framework guidance on the key elements that should be included in standards of care proto- cols for disaster situations. Ethical goals in medical care do not change, including during disasters â health care professionals are obligated al- ways to provide the best care they can under given circumstances. The committee defines the optimal level of health and medical care that can be delivered during a catastrophic event as crisis standards of care. Crisis standards of care: A substantial change in usual healthcare operations and the level of care it is possible to deliver, which is made necessary by a pervasive (e.g., pandemic influenza) or catastrophic (e.g., earthquake, hurricane) disaster. This change in the level of care de- livered is justified by specific circumstances and is for- mally declared by a state government, in recognition that crisis operations will be in effect for a sustained period. The formal declaration that crisis standards of care are in operation enables specific legal/regulatory powers and protections for healthcare providers in the necessary tasks of allocating and using scarce medical resources and implementing alternate care facility operations. To ensure that the best care possible is provided to patients in a catastrophic event, the nation needs robust and carefully-developed guid- ance for the public, healthcare professionals and institutions, and gov- ernmental entities at all levels. The committee sets forth the following vision for crisis standards of care: â¢ Fairnessâstandards that are, to the highest degree possible, rec- ognized as fair by all those affected by them â including the members of affected communities, practitioners, and provider organizations, evidence based and responsive to specific needs
LETTER REPORT 19 of individuals and the population focused on a duty of compas- sion and care, a duty to steward resources, and a goal of main- taining the trust of patients and the community â¢ Equitable processesâprocesses and procedures for ensuring that decisions and implementation of standards are made equitably o Transparencyâin design and decision making o Consistencyâin application across populations and among individuals regardless of their human condition (e.g., race, age, disability, ethnicity, ability to pay, socioeconomic status, preexisting health conditions, social worth, perceived obstacles to treatment, past use of resources) o Proportionalityâpublic and individual requirements must be commensurate with the scale of the emergency and degree of scarce resources o Accountabilityâof individuals deciding and implementing standards, and of governments for ensuring appropriate pro- tections and just allocation of available resources â¢ Community and provider engagement, education, and communi- cationâactive collaboration with the public and stakeholders for their input is essential through formalized processes â¢ The rule of law o Authorityâto empower necessary and appropriate actions and interventions in response to emergencies o Environmentâto facilitate implementation through laws that support standards and create appropriate incentives Five Key Elements of Crisis Standards of Care Protocols Based on a review of a number of standards of care protocols (Cali- fornia Department of Public Health, 2008; Virginia Department of Health, 2008; Powell et al., 2008; Colorado Department of Public Health and Environment, 2009; Minnesota Department of Health, 2008; The Commonwealth of Massachusetts Department of Public Health, May 2007; Levin et al., 2009; The Utah Hospitals and Health Systems Asso- ciation, 2009; Ontario Ministry of Health and Long-Term Care, 2008; VHA, 2008, 2009; Washington State Department of Healthâs Altered Standards of Care Workgroup, October 2008), published literature, and
20 CRISIS STANDARDS OF CARE GUIDANCE discussion at the workshop, the committee identified and defined five key elements that should be included in all crisis standards-of care- protocols. These five key elements each have several associated compo- nents (Table 1), which will be described in greater detail throughout the remainder of this report. To ensure that crisis standards of care protocols enable a response that is ethical, legal, and consistent within and across state borders, states in partnership with localities should ensure that they address, at a minimum, each of these key elements and corresponding components. Recommendation 1: Develop Consistent State Crisis Standards of Care Protocols with Five Key Elements State departments of health, and other relevant state agencies, in partnership with localities should ensure that crisis standards of care protocols include five key elementsâand associated componentsâdetailed in this report: â¢ A strong ethical grounding; â¢ Integrated and ongoing community and pro- vider engagement, education, and communi- cation; â¢ Assurances regarding legal authority and en- vironment; â¢ Clear indicators, triggers, and lines of re- sponsibility; and â¢ Evidence-based clinical processes and opera- tions.
LETTER REPORT 21 TABLE 1 Five Key Elements of Crisis Standards of Care Protocols and Associated Components Key Elements of Crisis Standards of Care Protocols Components Ethical considerations o Fairness o Duty to care o Duty to steward resources o Transparency o Consistency o Proportionality o Accountability Community and provider o Community stakeholder identification engagement, education, and with delineation of roles and involve- communication ment with attention to vulnerable popu- lations o Community trust and assurance of fair- ness and transparency in processes developed o Community cultural values and bounda- ries o Continuum of community education and trust building o Crisis risk communication strategies and situational awareness o Continuum of resilience building and mental health triage o Palliative care education for stakeholders Legal authority and o Medical and legal standards of care environment o Scope of practice for healthcare profes- sionals o Mutual aid agreements to facilitate re- source allocation o Federal, state, and local declarations of: o Emergency o Disaster o Public health emergency o Special emergency protections (e.g., PREP Act, Section 1135 waivers of sanctions under EMTALA and HIPAA Privacy Rule) o Licensing and credentialing o Medical malpractice
22 CRISIS STANDARDS OF CARE GUIDANCE Key Elements of Crisis Standards of Care Protocols Components o Liability risks (civil, criminal, Constitu- tional) o Statutory, regulatory, and common-law liability protections Indicators and triggers Indicators for assessment and potential man- agement o Situational awareness (local/regional, state, national) o Event specific o Illness and injuryâincidence and severity o Disruption of social and commu- nity functioning o Resource availability Triggers for action o Critical infrastructure disruption o Failure of âcontingencyâ surge capacity (resource-sparing strategies over- whelmed) o Human resource/staffing avail- ability o Material resource availability o Patient care space availability Clinical process and Local/regional and state government processes operations to include: o State-level âdisaster medical advisory committeeâ and local âClinical care committeesâ and âtriage teams.â o Resource-sparing strategies o Incident management (NIMS/HICS) prin- ciples o Intrastate and interstate regional consis- tencies in the application of crisis stan- dards of care o Coordination of resource management o Specific attention to vulnerable popula- tions and those with medical special needs o Communications strategies
LETTER REPORT 23 Key Elements of Crisis Standards of Care Protocols Components o Coordination extends through all ele- ments of the health system, including public health, emergency medical ser- vices, long-term care, primary care, and home care Clinical operations based on crisis surge re- sponse plan: o Decision support tool to triage life- sustaining interventions o Palliative care principles o Mental health needs and promotion of resilience DEVELOPING CRISIS STANDARDS OF CARE PROTOCOLS: A STATE PUBLIC HEALTH AUTHORITY PROCESS State authorities have the political and constitutional mandate to pre- pare for and coordinate the response to disaster situations throughout their state jurisdictions. Consequently, states in partnership with locali- ties have the responsibility for developing crisis standards of care proto- cols for use in disaster situations that result in severely limited healthcare resources. In most states, the state department of health holds this re- sponsibility. Some states have well-defined processes for establishing their protocols, but many others are still in development. This report con- tains guidance to assist state public health authorities in developing these crisis standards of care in partnership with their regional and local public health authorities, including the key elements that should be included in the crisis standards of care protocols and criteria for determining when crisis standards of care should be implemented. Although the state authority has the responsibility to establish, and ultimately determine, when to implement crisis standards of care, stake- holders should be important partners in this process, including healthcare professionals and institutions, public health and emergency management agencies, and state residents. The following is a framework for the de- velopment of crisis standards of care with a series of action steps for the state authority. This framework is based on the guidance laid out in this
24 CRISIS STANDARDS OF CARE GUIDANCE report and the experience of several states that have already developed, or started developing, protocols. 1. Outline Ethical Considerations: Convene a âGuideline Devel- opment Working Groupâ of appropriate stakeholders to establish ethical principles that will serve as the basis for the crisis stan- dards of care. The group should include (but is not limited to) representatives of regional and local health authorities, healthcare providers and representatives from professional asso- ciations, ethicists, patient advocates, public health and healthcare attorneys, community-based organizations, and members of the faith community. The ethics section in this report provides a comprehensive basis for these deliberations. Some states have also found it useful to develop scenarios to assist in recognizing and understanding the difficult decisions that will confront healthcare providers when resources are inadequate (New Jersey Hospital Association, 2008; Massachusetts Department of Public Health and Center for Public Health Preparedness, 2006). 2. Review Legal Authority for Implementation of Crisis Stan- dards of Care: Review existing legal authority for the imple- mentation of crisis standards of care and address legal issues related to the successful implementation of these standards, such as liability protections or temporary changes in licensure or certi- fication status or scope of practice. Revise and reform laws (statutory, regulatory) or policies as necessary (California De- partment of Public Health, 2008). These and other considerations are carefully set out later in the report. 3. Develop Guidance for Provision of Medical Care Under State Crisis Standards of Care: Establish an âAdvisory Committee,â which can include members of the Guideline Development Working Group (see above composition), but should also be ex- panded to include comprehensive representation from healthcare practitioners and professional associations in relevant specialties, including but not limited to nurses, physicians, emergency medi- cal technicians, a range of specialists from pediatrics to geriat- rics, mental health, palliative care, healthcare facilities, and other relevant entities such as the American Red Cross. Although this committee's deliberations will focus on complex medical issues, ethicists and public safety specialists should also be included in
LETTER REPORT 25 the committee to ensure that considerations from these disci- plines are integrated into the protocols. Crisis standards of care should be consistent with the ethical elements developed by the Guideline Development Working Group. This committee will find a comprehensive set of materials to inform its deliberations in the âIndicators and Triggersâ and âClinical Process and Op- erationsâ sections of this report. Note that this Advisory Com- mittee is a planning group for specific crisis standards of care situations. The Committee membersâ roles during a disaster should also be defined (see #5). 4. Conduct a Public Stakeholder Engagement Proc- ess: Although representatives of various healthcare and other in- terested professional groups and the public have been involved in drafting the ethical principles and crisis standards of care, a robust engagement process is also necessary to provide an op- portunity for review and comment by the provider and public community at large. Particular attention should be paid to out- reach to and input from vulnerable populations, including those with medical special needs. At these meetings, discussion should include an explanation of the need for crisis standards of care, the process for development of these standards, when and how crisis standards of care would be implemented, and an opportu- nity for those in attendance to comment on the drafts. Although these steps are an integral component of establishing standards of care protocols, few authorities have actively engaged in these efforts. Guidance on this process is provided in the âCommunity and Provider Engagementâ section. In addition, the state of New York and Seattle and King County both have integrated these into their protocol development processes (Powell et al., 2008; Li-Vollmer, 2009). Following the public engagement process, the ethical elements and crisis standards of care can be finalized, incorporating, as appropriate, changes based on comments received. Communica- tion and education on crisis standards of care with healthcare professionals and institutions and the public should continue as part of the general approach to public health emergency prepar- edness.
26 CRISIS STANDARDS OF CARE GUIDANCE 5. Establish a Medical Disaster Advisory Committee: During a disaster, this committee will provide ongoing advice to the state authority regarding changes to the situation and potential corre- sponding changes in the implementation of crisis standards of care. The Advisory Committee (see #3) responsible for develop- ing the crisis standards of care, or a subcommittee of those members, with additional members having the requisite expertise to perform this function for the specific disaster, can serve in this capacity. This group may be asked to provide input on a wider range of medical care issues during a disaster for which consis- tent state policy is required and thus should be able to call on technical medical expertise from a variety of areas according to the event specifics (critical care, emergency medical services, emergency medicine, toxicology, infectious disease, trauma/burn care, radiation injury, etc.). The composition of the committee should include individuals informed by real life experience who have had personal responsibility for coordinating healthcare sys- tem response and mitigation efforts to large-scale disaster events, with practical know how, and experience and understanding of the âsystemâ of response. Members should understand their roles and responsibilities and be available to the state during an event in person or at least via phone. Because providers may have other event-related obligations, this group should have several persons listed in each area of expertise. In addition, as will be described in more detail later in the report, during a disaster the Medical Disaster Advisory Committee will work closely at a lo- cal level with âclinical care committeesâ and âtriage teams.â Several states and localities have begun to develop scarce resource allocation protocols; however, few have provided guidelines for decision tools that will be needed during an incident (California Department of Public Health, 2008; Virginia Department of Health, 2008; Powell et al., 2008; Colorado Department of Public Health and Environment, 2009; The Commonwealth of Massachusetts Department of Public Health, May 2007; Levin et al., 2009; Minnesota Department of Health, 2008; The Utah Hospitals and Health Systems Association, 2009; Washington State Department of Health's Altered Standards of Care Workgroup, October 2008; Houston/Harris County Committee, 2007). Ontario has also devel- oped protocols that include additional consideration for crisis standards of care for patients with cancer or chronic renal disease/acute renal in-
LETTER REPORT 27 jury, as well as in regard to blood services and long-term care (Ontario Ministry of Health and Long-term Care, 2008). Local communities have also engaged in developing such ethical frameworks for their respective localities, including the Houston/Harris County area, which has devel- oped local community guidance for medical standards of care around pandemic influenza planning based on ethical deliberations and commu- nity input (Houston/Harris County Committee, 2007). In addition, the VHA has developed a protocol for allocation of scarce life-saving re- sources in the VHA during an influenza pandemic, along with an ethical framework that underlies the protocol (VHA, 2008, 2009). The state health departments in New York and California as well as the VHA have begun to develop guidance for allocation of ventilators. These protocols form the basis of much of this committeeâs deliberations and could serve as useful models for those states that are just beginning the process of developing crisis standards of care protocols. To ensure consistent im- plementation, states should ensure that protocol development is in accor- dance with the guidance and key elements outlined in this report, but existing state protocols could be used to avoid unnecessary duplication of effort and as a model for developing and implementing those key ele- ments at the appropriate level of detail. In recognition of the extensive work already undertaken by many states, and the need for other states to develop their own processes and protocols, the committee supports the GAOâs and UPMCâs Center for Biosecurity recommendations for a clearinghouse that should be devel- oped and housed by the HHS (GAO, 2008; Toner et al., 2009). This âclearinghouse,â or other easily accessed electronic repository, should include model standards of care protocols developed by the states, locali- ties, and other groups, relevant peer-reviewed literature, and model tools that could be integrated into planning and implementation strategies. ETHICAL FRAMEWORK An ethical framework serves as the bedrock for public policy. In de- veloping ethically sound policies for providing health care in disasters, the committee urges policy makers and communities to keep in mind current and past inequities in the allocation of healthcare resources and in healthcare outcomes and try to avoid these in future events through care- ful policy design. Among the lessons of Hurricane Katrina and other large-scale disasters is that those communities that are most vulnerable
28 CRISIS STANDARDS OF CARE GUIDANCE before a disaster are likely the most vulnerable during a disaster. Ethi- cally and clinically sound planning will aim to secure equitable alloca- tion of resources and fair protections for vulnerable groups as compared to the general population. During disasters, healthcare professionals may question whether they can maintain core professional values and behaviors. They wonder if it is possible to uphold core professional values and behaviors in the context of disaster. Is a nurse who provides critical care to 10 patients in a disas- ter acting unethically, as could be the case under ordinary circumstances? Professionals may ask which choices and standards might properly shift during a disaster, and when core ethical values draw a bright line that separates behaviors that are acceptable from those that are unacceptable. A useful disaster policy will help these persons judge how to act as good professionals even in emergency circumstances. Ethical Norms There are many principles that can contribute to an ethical frame- work. Various authors have articulated principles for public health and disaster ethics (Childress et al., 2002; University of Toronto, 2005). We focus here on a limited set of essential elements that reflect both core substantive ethical values and processes, and that can serve as a model or a starting point for local deliberations. Ethical values include the concept of fairness and the professional duties to care and to steward resources. Ethical process elements include transparency, consistency, proportional- ity, and accountability. Tensions often arise between different ethical principles. Duties to care for individuals and to steward resources may come into conflict, for example. The Guideline Development Working Group should determine how best to weigh competing demands given local values, priorities and available resources. Fairness The overarching ethical goal in developing crisis standards of care protocols is for them to be recognized as fair by all affected parties â even including those who might later be disadvantaged by the protocols. All subsequent ethical considerations reflect an effort to achieve such fairness. Fair crisis standards of care protocols will help communities
LETTER REPORT 29 and professionals act using just principles under harsh circumstances. Policy makers must seek to eliminate ways in which irrelevant factors such as class, race, ethnicity, neighborhood, or personal connections shift the burden of disaster toward vulnerable groups. By the same token, if particular groups receive favorable treatment, for instance in access to vaccines, this priority should stem from relevant factors (e.g., greater exposure or vulnerability) and promote important community goals (CDC, 2009c). Policies should reflect awareness of existing disparities in access to care, take account of the needs of the most vulnerable, and sup- port the equitable and just distribution of scarce goods and resources. Allocation choices based on evidence are one way to reflect the prin- ciple of fairness. This report will reference various disaster allocation schemes that rely on measurable and objective clinical parameters to help clinicians make difficult decisions in ways that are clear, consistent, and rational. Under duress, professionals may not be able to create fair allo- cation schemes in real-time. Disaster planning must include advance ethical guidance. Factors such as do-not-resuscitate (DNR) status have on occasion been considered in allocation schemes. However, DNR or- ders reflect individual preferences and foresight to establish advance di- rectives more than an accurate estimate of survival. Accordingly, DNR orders are not useful parameters for considering the allocation of scarce resources. Duty to Care The primary duty of a health care professional is to the patient in need of medical care. This duty holds true during disasters, including when providing care entails some risk to the clinician (AMA, 2004). Be- cause of this strong and deep obligation, health professionals are edu- cated primarily to care for individuals and less so for populations, although all health professionals also do have important public health obligations (Wynia, 2005). Even in crisis situations, however, clinicians cannot relinquish their obligations to individuals without sacrificing core professional values. The covenant between professional and patient gains rather than loses value in a public health disaster, when members of the community are justifiably frightened and numerous institutions and sup- port systems face great strain. Recognizing that scarce resources may restrict treatment choices, clinicians must not abandon, and patients should not fear abandonment, when an ethical framework informs
30 CRISIS STANDARDS OF CARE GUIDANCE healthcare disaster policy. Ethics elements of disaster policies should support the professionalâs duty to care. For instance, policies that outline role sequestration, sepa- rating those with triage responsibilities from those providing direct care, help preserve the professional integrity of healthcare workers. Those providing direct care can work to improve the health status of their indi- vidual patients and will not simultaneously be expected to make deci- sions that limit care. While professionals have a duty to care for patients, healthcare insti- tutions have a reciprocal duty to support healthcare workers (VHA, 2009). Personal protective equipment, engineering controls, and a variety of mechanisms to reduce the risk of infection demonstrate institutional obligations to protect workers who face risks in providing care (IOM, 2009b). Various types of disasters might call for other or additional pro- tections to safeguard healthcare workers who face risks, including mental health risks, as they provide care to the community. Duty to Steward Resources Healthcare institutions and public health officials also have a duty to steward scarce resources, reflecting the utilitarian goal of saving the greatest possible number of lives. Professionals must balance this duty to the community against that to the individual patient. Though clinicians face this dilemma under ordinary circumstances, the level of scarcity in a public health disaster exacerbates this tension. As scarcity increases, ac- commodating the two competing duties of care and stewardship will re- quire more difficult choices (Pesik et al., 2001). There is no uniform answer about how to weigh such competing val- ues, especially when under the duress of time constraints, emotional and physical stress, and while assimilating fluctuating or rapidly emerging new information. Addressing this balancing act under very difficult con- ditions, with the goal of making decisions that will be recognized as fair under the circumstances, makes it critical to establish ethical processes for decision-making.
LETTER REPORT 31 Ethical Process Transparency Public entities charged with protecting communities during disasters have profound responsibilities. They are called on to plan for foreseeable disasters. They must draw on the best available research, collect and de- velop expert opinion, and draw attention to gaps in knowledge and re- sources needed to protect the community. But ethically sound disaster policies require more than technical expertise. These policies must reflect specific values in choices about contested issues, such as priority setting for access to scarce resources and restrictions on individual choice. A public engagement process is crucial for drafting ethical policies that reflect the communitiesâ values and deserve its trust. However, though various scholars and public entities are currently in the midst of projects that engage the public, the goal of effective community participation in disaster policy development and evaluation is insufficiently realized at this time (CDC, 2009c; Li-Vollmer, 2009; Bernier, 2009; Bernier and Marcuse, December 2005). Given that a more severe influenza pandemic may emerge before the completion of a robust process of public engage- ment, officials must strive to communicate clearly those plans currently in place, and may also need to rely on real-time communication with communities and after-the-fact review. A truly inclusive process will not rely only on input from profes- sional groups and other organized stakeholders, but will also incorporate the views of those who are less well represented in the political process, but who may be greatly affected by policy choices. Children and their parents, older adults, persons with disabilities, and racially and ethnically diverse communities are more likely to feel keenly the impact of differ- ent choices in priority setting. Policies should reflect their values no less than those of other sectors of society. Enlisting the public to discuss a future disaster when current stressors overwhelm many will prove chal- lenging, but is nonetheless required. An ethical process will likely be iterative, characterized by responsible planning, transparency in underly- ing values and priorities, robust efforts toward public engagement, re- sponse to public comment, commitment to ongoing revision of policy based on dialogue and data, and accountability for support and imple- mentation. Values that drive policy should be explicitly stated so communities can articulate, examine, affirm or reject, and modify proposed choices.
32 CRISIS STANDARDS OF CARE GUIDANCE Transparency also implies candor in communication about disasters, from clinicians to patients and throughout all levels of the healthcare sys- tem. Limitation of choice for both patients and providers is a reality of disaster and will affect many aspects of healthcare delivery. Profession- als and patients will have fewer treatment options. Evidence-based crite- ria, rather than patient preference or clinical judgment, will determine access to the most limited resources. Though patient autonomy is re- duced by the circumstances of disaster, patients still deserve clear infor- mation about available choices, respect for preferences within resource constraints, and empathic acknowledgment of the sometimes dire conse- quences of resource limitation. Consistency Consistency in treating like groups alike is one way of promoting fairness. The public may find that scarce resources have not been allo- cated fairly if patients at different hospitals in the same affected area re- ceive vastly different levels of care. Consistent policies may also help eliminate unfair local efforts to discriminate against vulnerable groups on the basis of factors such as race or disability. However, efforts to keep policies consistent across institutions or geographic regions may limit local flexibility in implementing guidance. The capacity for local com- munities to reflect their values in allocating scarce resources stands in tension with the goal of promoting consistency. Flexibility is necessary, but requires careful deliberation and documentation where local practices do not follow common guidance. Proportionality Disaster policies will include aspects that are burdensome to indi- viduals and professionals. Burdens such as social distancing, school clo- sures, or even quarantine should be necessary and commensurate with the scale of the public health disaster. Those restrictions imposed must serve important public needs, such as the need to limit spread of an infec- tious agent, and must be appropriately limited in time and scale accord- ing to the scope and severity of the disaster.
LETTER REPORT 33 Accountability Effective disaster planning will require individuals at all levels of the healthcare system to accept and act upon appropriate responsibilities. As part of their duties to care and to steward scarce resources, individual clinicians are responsible for a good faith effort toward education in im- portant disaster-related concepts and knowledge of local planning efforts (AMA, 2004). Local facilities are accountable for disaster policies. Gov- ernment entities are accountable to their communities to plan and imple- ment policies related to disasters, and members of the community must know which entities take responsibility for various elements of disaster policies. For instance, practitioners concerned about the provision of per- sonal protective equipment should know which entity is accountable for that domain and to whom they should address concerns. All decision- makers should be accountable for a reasonable level of situational awareness and for incorporating evidence into decision-making, includ- ing revising decisions as new data emerge. Like transparency, consis- tency and proportionality, accountability before, during and after a disaster is a key ingredient in building and maintaining trust. Applying the Ethics Framework: Ventilator Allocation The ethics framework described above serves as a guide in develop- ing disaster policies. We examine here the hard choices involving the allocation of ventilators, beginning at the systems level and then for indi- vidual patients. Ventilators, of course, are only one of many elements that may sustain the life of a critically ill patient. Appropriate surge plan- ning will balance the need to stockpile a range of critical resources, as well as staff and space to provide treatment. However, ventilator alloca- tion serves as a useful example of decision making under conditions of scarcity for several reasons. Ventilators are large and expensive; facilities cannot provide more than a certain number of ventilators, even when all surge resources are in play. Furthermore, ventilators require trained staff to operate them and availability of necessary medications, and thus de- pend on the additional scarce resources of personnel and drugs. In an influenza pandemic, severe respiratory illness will also increase the need for and scarcity of ventilators. Finally, a ventilator is a discrete resource that cannot be titrated or shared effectively, and whose absence is highly likely to result in death.
34 CRISIS STANDARDS OF CARE GUIDANCE First, we will examine ventilator allocation as applied to a specific group. A number of disaster policies address the controversial issue of how chronically ventilator-dependent patients figure in triage schemes. The VHA provides a thoughtful review of this problem, contrasting two different policy choices (VHA, 2009). It notes that the New York State Task Force on Life & the Law argued for exempting patients in long- term care facilities from ventilator triage protocols because extubation of stable chronic care patients would force clinicians in long-term care fa- cilities into an unacceptable reversal of their caring role (NYSDOH/NYS Task Force on Life & the Law, 2007). Moreover, the reallocation of ven- tilators from chronic care patients would impose an unfair burden on the disabled, in part based on subjective quality-of-life judgments rather than on more objective estimates of survival. The Task Force found that pa- tients in chronic care facilities should maintain access to ventilators while in those facilities. However, if transferred to an acute care facility, such patients should enter the triage system. In contrast, the World Health Organization concluded that chronic care patients should be in- cluded with all other patients in triage protocols, holding that all must share the sacrifice involved in triage equally (WHO, 2006). The VHA found that viable ethical arguments could support either position. The VHA chose to exclude from triage protocols those patients chronically supported by ventilators and living in long-term care facilities or at home, arguing that this choice represented the best available balance be- tween the duty to care and to exercise stewardship of scarce resources. Regarding ventilator allocation as applied to individual patients and healthcare professionals, disaster plans must minimize the need for such painful choices by requiring that all possible steps to augment and substi- tute for scarce resources precede any reallocation of scarce resources. Yet, if need sufficiently overwhelms resources, not all patients who might benefit from critical care resources can receive them. Alternative allocation criteria could proceed on a first-come, first- served basis or through a lottery system, but either of these systems would result in excess mortality because some patients who receive ven- tilator treatment will die, and others who might have survived will die without it. Thus, this model of allocation would not uphold the duty to steward resources wisely and save the greatest possible number of lives. Several disaster policies reviewed by this committee require the use of evidence-based tools to assess the likelihood of benefit from critical care resources, and the reallocation of such resources under conditions of ex- treme scarcity to patients with the greatest likelihood of benefit when a
LETTER REPORT 35 clear and substantial difference in prognosis exists. These policies com- port with an ethical framework that stewards resources and saves the greatest number of lives. It is important that these policies be explained, discussed, and considered by states developing crisis standards of care. Many clinicians are justifiably troubled by the prospect of discon- tinuing life-sustaining treatment from a patient in a disaster, even though the purpose is to save lives. Clinicians at the bedside working under ex- treme circumstances deserve clarity, and without it they may be reluctant to implement a disaster standards of care protocol. Certainly, critical care physicians may discontinue life-prolonging treatment in response to a patientâs request. The disaster context is agonizing because treatment could be withdrawn without or against the patientâs expressed wishes. Ventilator withdrawal also requires an order not to resuscitate because resuscitation efforts require the use of ventilators. Outside of crisis situa- tions, these orders typically require consent of patients or their surrogate decision makers, but disaster triage protocols may permit doctors to initi- ate such orders when life-sustaining treatment is reallocated. What a disaster triage policy based on the duty to steward resources would do is effectively override individual patient preferences and in- stead supply resources based on evidence-based assessments of the bene- fit of the treatment relative to its scarcity. Thus, treatment offered in circumstances of a disaster should be understood as provisionalâif the intervention is unsuccessful, it may be discontinued in order to provide the best possible care to as many as possible. When resource scarcity reaches catastrophic levels, clinicians are ethically justified in using those resources to sustain life and well-being to the greatest extent possible. In the case of discontinuing life-sustaining treatment such as a ventilator, clinicians look to all ethical elements of the framework, starting with the principle of fairness. This hard choice stems from adherence to the duties to provide care and steward resources and follows guidance for ethical processes, including transparency, con- sistency, proportionality, and accountability. Despite removing a vital treatment, a clinician must continue to pro- vide compassionate care. In stewarding resources, palliative care will be prioritized to those critically ill patients who do not meet allocation crite- ria for scarce resources. Transparency regarding limited resources forms a critical part of communication even before, but certainly during, a patientâs hospital admission. Clinicians and facilities need to inform patients and families of the time-limited nature of trials of ventilator therapy and other scarce
36 CRISIS STANDARDS OF CARE GUIDANCE resources. Consistency in applying evidence-based triage tools helps guarantee fairness in access to resources, and provides professionals a clear rationale for triage decisions. Proportionality requires that this dras- tic infringement on the autonomous choice of patients or the professional judgment of clinicians is not invoked unless all other reasonable surge strategies have been implemented. Finally, accountability demands that professionals follow triage guidelines for assigning scarce resources and can support their decisions based on good-faith efforts to adhere to disas- ter policies. Professionals reasonably insist that adequate legal protection must accompany this shift from ordinary to crisis standards of care. Crisis standards permit clinicians to allocate scarce resources so as to provide necessary and available treatments to patients most likely to benefit. Crisis standards do not permit clinicians to simply ignore profes- sional norms and act without ethical standards or accountability. Crisis standards justify limiting access to scarce treatments, but neither the law nor ethics support the intentional hastening of death, even in a crisis. Recommendation 2: Adhere to Ethical Norms in Crisis Standards of Care When crisis standards of care prevail, as when ordi- nary standards are in effect, healthcare practitioners must adhere to ethical norms. Conditions of over- whelming scarcity limit autonomous choices for both patients and practitioners regarding the allocation of scarce healthcare resources, but do not permit ac- tions that violate ethical norms. COMMUNITY AND PROVIDER ENGAGEMENT, EDUCATION, AND COMMUNICATION Meaningful community engagement efforts for the general public, community leaders, and healthcare professionals are critical for the suc- cessful development, dissemination, and implementation of crisis stan- dards of care. Community engagement is defined âas structured dialogue, joint problem solving, and collaborative action among formal authorities, citizens at-large, and local opinion leaders around a pressing public mat- terâ (Schoch-Spana et al., 2007). Such community engagement involves two-way communication between governmental officials and community stakeholders who work together to understand each othersâ perspectives
LETTER REPORT 37 while also tackling complex issues at hand. The end result is a commu- nity-based participatory process that considers the potential crisis stan- dards of care that may need to be implemented, with all parties understanding why such standards are necessary and how these standards will be applied within a community context (Schoch-Spana et al., 2007; Bernier, 2009). Community stakeholders can be divided into (1) healthcare profes- sionals and institutions who would be asked to implement crisis stan- dards of care, and (2) non-healthcare professionals and entities such as patients, family members, or other community laypersons who would be directly impacted by the implementation of such standards of care. Both groups are part of the same community, but specific engagement efforts aimed at both types of community stakeholders, across all phases of dis- aster planning and response, are necessary to ensure effective engage- ment and engender trust in the processes and systems put in place (Table 2). Engagement and communication with stakeholders even after a disas- ter has occurred (the so-called ârecoveryâ phase) is equally important to help stakeholders understand the standards-of- care processes that were employed during the time of crisis as well as to help deal with the after- math of the crisis scenario. TABLE 2 Community and Provider Engagement, Education, and Com- munication Preincident o Cultural competency training and linguistically ap- (preparedness) propriate communications o Transparency, engagement, outreach and trust es- tablishment with community-based organizations, faith-based organizations, and community repre- sentatives o Input into core values or principles to guide stan- dards and implementation o Understanding of the fundamental ethical dilem- mas involved in decisions that might be made nec- essary by crisis situations o Input on how to avoid the need to implement crisis standards of care, such as through improved under- standing and support for a culture of preparedness.
38 CRISIS STANDARDS OF CARE GUIDANCE Incident o Establish and promote ongoing communication (response) and situational awareness o Mental health, palliative care, and bereavement in- terventions/ provider self-care training o Develop and communicate resilience strategies o Ensure equitable care of vulnerable populations Postincident o Mental health screening and interventions (recovery) o Continued community engagement and establish- ment of predisaster clinical roles and patient rela- tionships o Continued development and promotion of resil- ience strategies o Debriefing and learning to facilitate improved fu- ture response, including revisions to crisis stan- dards of care as appropriate Preincident Community Engagement The transition from an individual-based focus to a population-based focus requires federal, state, local, and tribal community level involve- ment, collaboration, coordination, and cooperation. These governmental entities should reach out to both traditional and non-traditional partners, including new partners in preparedness and response, such as law en- forcement, emergency management, and other responders necessary in comprehensive emergency planning and response efforts (Lurie et al., 2006). In partnership, these entities should then work with healthcare providers and their institutions to communicate with and engage com- munity stakeholders in the disaster-planning phase, explaining that crisis standards of care will be applied in disasters during unresolvable circum- stances of resource scarcity. While it is important to establish discussions specific to the emergency response topics being considered, it is equally important to work with existing community networks that may already have processes in place that can allow for improved dialogue. Such net- works can be made up of a variety of community-based and faith-based organizations, with identification of community leaders to help facilitate the process (ASTHO, 2009). Although community stakeholder engage- ment can be accomplished through a variety of means in advance of the disaster, the foundation of any such engagement rests on establishing trust among stakeholders anticipated to be involved, including govern-
LETTER REPORT 39 mental entities, healthcare providers and their institutions, and the lay public. The establishment of trust includes open and honest communica- tion regarding the realities of current resource limitations, scarce re- source environments and the impact of catastrophic events on the healthcare system, and its ability to provide the usual level of care that community members otherwise expect. The reasoning behind the deci- sion to implement crisis standards of care in emergency situations must be explained with a high degree of transparency to all stakeholders in- volved. This engagement dialogue should be inclusive of the opportunity for community stakeholders to articulate underlying community values and ethical principles of fairness and social justice to ensure that healthcare providers apply these principles appropriately during times of crisis (Houston/Harris County Committee, 2007; Powell et al., 2008; Li- Vollmer, 2009). An example of such an engagement of the public in the preparedness process is the Illinois Faith-Based Pandemic Flu Prepared- ness ambassadorâs training program. This program has trained more than 500 faith-based leaders and their congregations in flu preparedness is- sues, National Incident Management System concepts, and American Red Cross cardiopulmonary resuscitation instruction. This form of en- gagement is engendering trust, cooperation, and a feeling of partnership among the various stakeholders in the process, setting the stage for fur- ther preparedness topics of discussion, such as crisis standards of health- care delivery. Other examples of organizations engaging communities are the USA Freedom Corpsâ branch, the U.S. Citizens Corps established after September 11, 2001, and the Medical Reserve Corps and Commu- nity Emergency Response Team programs. They have ongoing contribu- tions being made to community response efforts throughout the states (Citizen Corps, 2009). Every effort should be made to facilitate stakeholder input into the deliberative process because implementation of crisis standards of care will likely require crossing the boundaries of established community ethical, philosophical, religious, legal, and value-based standards. These standards typically exist to protect an individual patientâs health and well-being. Discussions about palliative care, dying, and death should be explicit components of this dialogue so that stakeholders can be assured that the healthcare system will not abandon them when resources are scarce. Additional attention should be paid to the disaster mental health needs of both healthcare providers and community stakeholders, with
40 CRISIS STANDARDS OF CARE GUIDANCE particular focus on those psychological needs that will be accentuated during and after times of crisis. Governmental leaders and authorities who actively seek community stakeholders and work to understand their perspectives in advance of a disaster are believed to be better able to work with these stakeholders in the midst of a response effort (Schoch-Spana et al., 2007). Thus, while communication and engagement form key components of predisaster planning, it is equally the cornerstone for maintaining understanding and trust during the crisis itself as resource scarcity becomes a stark reality. Building on the trust and credibility that were established during the pre- disaster phase, governmental entities in partnership with healthcare pro- fessionals and institutions will need to provide clear, timely, effective, and appropriate crisis risk communication so that community stake- holders will receive needed ongoing situational awareness of the disas- terâs impact on precious health system resources as the situation unfolds. Although a number of crisis risk communication tools are available, evaluation of such tools is beyond the scope of this committeeâs work. However, it should be noted that the CDCâs Crisis & Emergency Risk Communication curriculum includes the components of such a strategy and is available for use via the CDC website (CDC, 2009e). Crisis risk communication will assist community stakeholders in understanding their own health risk and help mitigate potential demand on limited sys- tem resources, and also help reinforce the predisaster discussions with community stakeholders so they can prepare for the scarce resource situation at hand. A well-integrated communications plan that is part of an overall dis- aster response strategy will increase situational awareness, mitigate and address rumors, and ensure that community concerns and anxieties are addressed promptly as the situation unfolds through bidirectional com- munications (Sheppard et al., 2006; Andrulis et al., 2007). This involves the development of educational materials, emergency messaging, and other systematic strategies by which to disseminate important informa- tion to stakeholders including members of the media. Additionally, in- formation about palliative care options and end-of-life care needs should be made an explicit part of the crisis risk communication efforts (Gava- gan et al., 2006). Mental health considerations must also play a central role in this communication effort so that individuals (and the community as a whole) can learn to cope with complex disaster mental health con- cerns tied to crisis standards of care, namely fears, anxiety, perceived or real loss of control, traumatic grief/depression, posttraumatic stress dis-
LETTER REPORT 41 order (PTSD), and other disaster-related mental health needs and social changes created by necessary crisis standards of care. Finally, in addition to improved planning and greater trust, pre- incident community engagement in planning can help create or build al- liances and collaborative efforts that aim to avoid the necessity of im- plementing crisis standards of care. Community engagement can lead to greater support (financial and otherwise) for preparedness efforts, for example. Community Engagement to Improve Resiliency As there are likely to be substantive population-level mental health risks from a mass casualty public health emergency that requires crisis standards of care, there is also an opportunity to promote resilience at the individual and population levels to mitigate these risks. For example, varied crisis standards of care (e.g., allocation of scarce resources, com- munity mitigation strategies) may either be enhanced or bitterly opposed based on levels of public engagement and trust in recommended public health crisis standards of care. Although scant empirical data are avail- able, it is conceivable that desired public behaviors can be enhanced by early and sustained community engagement (Germann et al., 2006; HHS, 2003). Undesirable (e.g., anti-social or even violent) behaviors and po- tential social disorganization can be lessened through these efforts, re- sulting in improved resilience for the individual and the system. Proactive engagement and communications with the public represent a critical opportunity to facilitate individual and community resilience that will hopefully encourage concrete actions they can take now to lessen the potential impacts from events requiring crisis standards of care as well as an ongoing commitment to integrate these issues during response and recovery phases as information changes. Customized, event-specific risk communications, emergency public health information linked with resilience enhancing psychoeducational coping information, and coping strategies that use social networks to cope with fears and loss may serve to âinoculateâ the population and the healthcare workforce from the effects of a mass casualty event requiring crisis standards of care. For example, in a pandemic incident, a key resil- ience component could be a âCoping with scarce resources/mass casualty eventsâ module disseminated through emergency public information and messaging. Although these population-level behavioral resilience and
42 CRISIS STANDARDS OF CARE GUIDANCE coping strategies are not currently available, they could be developed to enhance resilience by supporting natural social support systems and ex- pected reactions by facilitating and encouraging natural coping through the use of individual and family âresilience plansâ(Schreiber, 2005). In these scenarios, creating mechanisms for supporting and conducting bidi- rectional communications between the citizenry and public health offi- cials can enhance population-level behavioral resilience. The extent of an enhanced population resilience may have a direct bearing on reducing the surge demand on the healthcare system and other key critical infrastruc- tures on the part of the public and facilitate the willingness of the health- care workforce to operate under crisis standards of care. Thus, it is important to develop a national platform to support resilience that can customized by communities at the local level. Improving Trust with Vulnerable Populations Building trust is particularly important in more vulnerable popula- tions, including those with preexisting health inequities and those with unique needs related to race, ethnicity, culture, immigration, limited Eng- lish proficiency, and lower socioeconomic status. Individuals from these communities may have accentuated mistrust for governmental decision making and the healthcare system, and these concerns may parlay into their questioning the fairness and equity of the process during the im- plementation of crisis standards of care. Concerns for other vulnerable populations such as children, older adults, persons with disabilities, and individuals with medical special needs must also be considered during disaster planning and response because these factors may also impact morbidity and mortality. The needs, challenges, and barriers to caring for these specific community stakeholders must also be considered for inte- gration into the overall disaster response effort prior to the implementa- tion of crisis standards of care. Healthcare providers and their institutions should incorporate appropriate cultural competencies to address issues inherent within these disadvantaged communities (Pastor et al., July 2006; Schoch-Spana et al., 2007; Andrulis et al., 2007). A recent collabo- ration of governmental and non-governmental entities called attention to issues related to working with these populations in an effort to ensure their integration into emergency preparedness and response activities. This culminated in the release of the following National Consensus Statement:
LETTER REPORT 43 The integration of racially and ethnically diverse com- munities into public health emergency preparedness is essential to a comprehensive, coordinated federal, state, tribal, territorial, and local strategy to protect the health and safety of all persons in the United States. Such a strategy must recognize and emphasize the importance of distinctive individual and community characteristics such as culture, language, literacy, and trust, and pro- mote the active involvement and engagement of diverse communities to influence understanding of, participation in, and adherence to public health emergency prepared- ness actions (Drexel University Center for Health Equal- ity, 2008). Once the crisis has passed, attention should be given to ongoing en- gagement with community stakeholders to help optimize restoration of function and well-being at both the individual and community levels in the post-recovery phase. Particular attention should be given to mental health triage and needs, especially bereavement, as individuals begin the process of recovery from the dual impacts of both the crisis medical care environment and other non-medical impacts of the incident. Health edu- cation, risk communication, community outreach, and other well- established strategies should be incorporated in the recovery phase to ensure that the needs of the communityâparticularly those from popula- tions that may have been disproportionately impacted during the crisisâ are attended to as the medical system returns back toward normalcy (Schoch-Spana et al., 2007). The community should also be involved in post-incident learning and improvement processes. Trust in the health care system will remain im- portant long after the crisis has passed. Ongoing community engagement offers the opportunity to build and enhance trust, even if incident re- sponse did not meet all stakeholdersâ expectations. Community engage- ment in the learning process can also offer the benefit of varied insights into the response process and how to improve it.
44 CRISIS STANDARDS OF CARE GUIDANCE Recommendation 3: Seek Community and Provider Engagement State, local, and tribal governments should partner with and work to ensure strong public engagement of community and provider stakeholders, with particu- lar attention to the needs of vulnerable populations and those with medical special needs, in: â¢ Developing and refining crisis standards of care protocols and implementation guidance; â¢ Creating and disseminating educational tools and messages to both the public and health professionals; â¢ Developing and implementing crisis commu- nication strategies; â¢ Developing and implementing community re- silience strategies; and â¢ Learning from and improving crisis stan- dards of care response situations. LEGAL ISSUES IN EMERGENCIES Significant legal challenges may arise in establishing and implement- ing crisis standards of care. Questions of legal empowerment of various actions to protect individual and communal health are pervasive and complicated by interjurisdictional inconsistencies. The law must inform prevailing standards of care and create incentives for actors to maximize individual and communal health, while also respecting both individual and community rights as much as possible. Distinguishing Medical and Legal Standards of Care and Scope of Practice Modern studies and assessments improve our understanding of how healthcare services change during emergencies to ensure optimal health outcomes (AHRQ, 2005b; GAO, 2008; AMA, 2007; Romig, 2009; Christian et al., 2006; Kanter, 2007). Various actors must be able to or- ganize and effectively use limited medical resources consistent with âcri-
LETTER REPORT 45 sisâ standards of care. Yet, the question of which professional standard changes, whether medical or legal, is less certain. Medical and legal standards of care may be conflated and confused, suggesting a change in one standard automatically leads to a change in the other. Medical and legal standards of care, however, are not synonymous. Medical standards of care describe the type and level of medical care required by professional norms, professional requirements, and institu- tional objectives (AHRQ, 2005b; Hick, et al., 2009; Pegalis, 2009). Medical standards of care vary (1) among types of medical facilities such as hospitals, clinics, and alternate care facilities, and (2) based on pre- vailing circumstances, including during emergencies. Medical standards of care should not be confused with a healthcare practitionerâs scope of practice or associated privileges (Hick et al., 2009; Pegalis, 2009; Curie and Crouch, 2008). Scope of practice refers to the extent of a licensed or certified professionalâs ability to provide health services pursuant to their competence and license, certification, privileges, or other lawful author- ity to practice (AHRQ, 2005b; Wise, 2008; Lewandowski and Adamle, 2009). Legal standards of care may be defined as the care and skill that a healthcare practitioner must exercise in particular circumstances based on what a reasonable and prudent practitioner would do in similar cir- cumstances (Mastroianni, 2006; Dobbs, 2000; Hood v Phillips, 19771). Legal standards of care are necessarily flexible according to the fact and situation, and subject to differing interpretations nationally (Dobbs, 2000). Further, the legal standards of care may vary from state-to-state. Yet legal standards of care do not always approximate medical standards. For example, courts assessing standards of care may determine that pre- vailing medical practice is insufficient or unacceptable in exceptional cases (Canterbury v Spence,19722). Flexibility of the legal standard of care may be beneficial in emergencies, but does not always lend to pre- dictable outcomes when legal disputes arise. This emphasizes the impor- tance of a formal recognition by the state of situations when crisis standards of care are necessary, along with the provision of guidance appropriate to the resource scarcity at issue. Facing uncertainty as to how courts will assess crisis standards of care, healthcare practitioners may react negatively to actual or perceived risks of liability. As discussed be- low, legal protections may assure healthcare practitioners who act in 1 Hood v Phillips, 554 S.W.2d 160 (Tex. 1977). 2 Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).
46 CRISIS STANDARDS OF CARE GUIDANCE good faith that they may not be held liable for their civil wrongs that cause unintended harms to patients during emergencies. The Changing Legal Environment During Declared Emergencies In non-emergencies, existing laws and policies offer reasonable guidance on the empowerment of actors and entities to allocate health resources and deliver health care. During declared states of emergency, however, the legal environment changes (Hodge and Anderson, 2008). Emergency declarations trigger an array of non-traditional powers that are designed to facilitate response efforts through public and private sec- tors. Emergency laws may (1) provide government with sufficient flexi- bility to respond; (2) mobilize central commands and infrastructures; (3) encourage response efforts by limiting liability; (4) authorize interstate recognition of healthcare licenses and certifications; (5) allocate health- care personnel and resources; and (6) help to change medical standards of care and scope of practice (Hodge et al., 2009b). The extent of legal powers during emergencies, however, depends on the type of emergency declared. The federal government, every state, many territories, and some local governments may declare either general states of âemergencyâ or âdisasterâ in response to crises that affect the publicâs health. Such declarations largely authorize emergency manage- ment agencies and others to use general legal powers to coordinate emergency responses. HHS and more than half the states may also de- clare states of âpublic health emergencyâ based in part on the Model State Emergency Health Powers Act (Hodge, 2006; Centers for Law and the Publicâs Health, 2001). The federal government and some states may declare both states of âemergency or disasterâ and âpublic health emer- gency,â which can lead to confusion as divergent governmental powers and entities seek to respond in overlapping ways. From these varying emergency declarations arise a host of powers and protections that may impact the setting of standards of care depend- ing, in part, on real-time legal interpretations. Through what has been labeled âlegal triage,â hospital administrators, emergency planners, EMS providers, public health practitioners, and their legal counsel must priori- tize legal issues and solutions to facilitate legitimate public health re- sponses during declared states of emergencies (Hodge and Anderson, 2008). Practicing legal triage is not easy as needs and objectives among
LETTER REPORT 47 agencies during declared emergencies may conflict. Ultimately, however, legal decision making in real-time during emergencies may affect im- plementation of crisis standards of care. Recommendation 4: Provide Necessary Legal Protec- tions for Healthcare Practitioners and Institutions Implementing Crisis Standards of Care In disaster situations, tribal or state governments should authorize appropriate agencies to institute crisis standards of care in affected areas, adjust scopes of practice for licensed or certified healthcare practitioners, and alter licensure and credentialing practices as needed in declared emergencies to create incentives to provide care needed for the health of individuals and the public. Legal Challenges Concerning Standards of Care in Declared Emergen- cies Healthcare providers responding to public health emergencies in- volving scarce resources may confront numerous legal challenges, as summarized below. Providers should consult their state and local legal partners (e.g., state Attorney Generalâs office, local government counsel, hospital attorneys) before and during emergencies for additional, specific information due to variations in law and healthcare practice across states. Legal Authorization to Allocate Personnel, Resources, and Supplies Legal authorization is generally required to shift the provision of care and allocate resources (e.g., personnel, medical supplies, and physi- cal space) during emergencies. Emergency declarations and ensuing or- ders, as noted above, can be the first step in authorizing such changes and providing liability protections (Louisiana Senate Bill, 2008 3 ). Many statesâ statutory emergency laws, for example, facilitate the recognition of out-of-state healthcare licenses and certificates for the limited duration of a declared emergency to allow for the interstate sharing of healthcare 3 Louisiana Senate Bill No. 301; Act No. 538, Â§735.3, (2008).
48 CRISIS STANDARDS OF CARE GUIDANCE personnel. Memoranda of understanding (MOU) and mutual aid agree- ments can also facilitate the sharing of health care and other necessary resources when they are scarce during emergencies (Stier, 2009). The Emergency Management Assistance Compact (EMAC) formalizes inter- state mutual aid among all 50 states and the District of Columbia (Emer- gency Management Assistance Compact, 1996 4 ). To meet regional and substate resource-sharing concerns, regional, state, county, city, and even local hospital MOUs have also been developed (Hodge et al., 2009a; State of Connecticut, 2006; County of Santa Clara, March 2007; North Central Texas Trauma Regional Advisory Council, 2009). Liability Risks and Protections for Healthcare Practitioners Liability is a prevalent concern among healthcare providers and enti- ties. This concern may be heightened when providing services during emergencies in which routine healthcare practices and responsibilities change. Potential liability claims against practitioners and entities can result from alleged civil, criminal, and Constitutional violations implicat- ing healthcare providers, volunteers, and government or private entities. Liability may arise from claims of medical malpractice, discrimination, invasions of privacy, or violations of other state and federal statutes (e.g., Emergency Medical Treatment and Labor Act, or EMTALA) (Courtney, 2008). Legal causes of action in disaster are rare, but many healthcare providers and entities remain concerned about their potential exposure to liability risks. Existing liability protections are often described as a âpatchworkâ (Swendiman and Jones, 2009; CDC, 2009b). There are no comprehen- sive national liability protections for healthcare providers or entities in all settings. However, an array of state and federal liability protections exist for providersâparticularly volunteers and government entities and offi- cials acting in their official dutiesâwho act in good faith and without willful misconduct, gross negligence, or recklessness (Hoffman et al., 2009; Rosenbaum et al., 2008; TFAH, 2008). Some liability protections, including âGood Samaritanâ statutes, Volunteer Protection Acts, and Tort Claims Acts, may apply without an emergency declaration (Centers for Law and the Publicâs Health, 2004; Hodge, 2006; Volunteer Protec- 4 Emergency Management Assistance Compact, Public law 104-321, 104th Congress, 2nd sess. (October, 1996).
LETTER REPORT 49 tion Act of 19975). Other protections (e.g., those pursuant to EMAC) are triggered by an emergency declaration (Centers for Law and the Publicâs Health, 2004). Specific declarations, such as those pursuant to the federal Public Readiness and Emergency Preparedness Act, may also provide liability protections (Binzer, 2008). Individuals may also receive special protections when deployed through formalized response teams. More limited liability protections exist for entities and paid, private-sector healthcare workers, although some states also provide immunity for compensated workers (Hoffman et al., 2009; Virginia, 20036; Louisiana Senate Bill, 20087). Additionally, liability protections may stem from the waiver of sanctions for failing to comply with certain federal statutes during emergencies. This existing patchwork of liability protections can complicate plan- ning and response efforts and deter emergency response participation. Emergency liability protections often have limitations. They might only provide coverage after an emergency declaration and for responders who follow disaster plans or act under government authority, uncompensated volunteers, good-faith acts or omissions, and specified time periods or personnel. In addition, most liability protections do not provide immu- nity or indemnify practitioners for acts that constitute gross negligence, willful or wanton misconduct, or crimes. Absent national comprehensive liability protections, state and local governments should explicitly tie ex- isting liability protections (e.g., through immunity or indemnification) for healthcare practitioners and en- tities to crisis standards of care. An additional concern of many healthcare practitioners is the extent to which medical malpractice and other forms of insurance will cover medical mistakes or care given outside a providerâs scope of practice under crisis standards of care situations. Medical malpractice insurance coverage in declared emergencies differs across states and is dependent on specific insurance policy language. To protect healthcare practitioners from rate increases following frivolous malpractice claims, state law could restrict medical malpractice carriers from increasing premiums of 5 Volunteer Protection Act, Public Law 105-19, 42 U.S.C. Â§14501 et seq (1997). 6 Virginia General Assembly Chapter 507, Â§ 8.01-225.01 (March 16, 2003). 7 Louisiana Senate Bill No. 301, Act No. 538, Â§735.3, (2008).
50 CRISIS STANDARDS OF CARE GUIDANCE healthcare practitioners who face unsuccessful claims arising from their provision of care in declared emergencies. In considering potential claims of medical malprac- tice against healthcare practitioners arising from the delivery of health care in declared emergencies, courts may (1) take notice of the legal effect of chang- ing standards of care during emergencies, and (2) consider whether adherence to guidance in this Re- port provides sufficient evidence of meeting the stan- dard of care. Balancing Individual Legal Rights and Responsibilities and Communal Objectives At the core of emergency legal issues is the need to balance individ- ual and communal interests to protect the publicâs health. Though simply stated, balancing respective legal interests in emergencies is complex (Gostin, 2008). The interests of individuals and the community may con- flict, leading to difficult issues in the setting and implementation of crisis standards of care. Due process and other constitutional protections may differ among autonomous adults and children or other wards of the state (e.g., prisoners, persons lacking mental competence) (Gostin, 2008). Non-autonomous individuals may enjoy special Constitutional protec- tions intended to prevent individual harms. For example, government may be legally required to protect the health of minors even though adults may not be similarly protected (Hodge, 2009). At a minimum, all persons enjoy some level of procedural due process related to govern- mental decisions to establish standards of care. How much process is due under specific circumstances? The key is to balance the publicâs need to allocate resources in real-time with an individualâs right to access avail- able care and assess key decisions. Individual privacy must also be as- sessed against the need for government or others to provide adequate care or review identifiable health data in health emergencies (Hodge et al., 2004). Decisions concerning standards of care that disproportionately affect individuals on grounds of ethnicity, religion, race, or other pro- tected classes may raise claims of equal protection violations (Gostin, 2008; Swendiman and Jones, 2009).
LETTER REPORT 51 Antidiscrimination Protections for Patients Discrimination in the provision of health services can also present li- ability issues during health emergencies. Federal law prohibits discrimi- nation against individuals on the basis of race, color, or national origin (Title VI of the Civil Rights Act of 1964); age (Age Discrimination Act); or disability (Section 504 of the Rehabilitation Act; Americans with Dis- abilities Act) (Age Discrimination Act of 1975 8 ; Americans with Dis- abilities Act 9 ). Violation of these require ârationalâ documentation as to why this constituted a burden that could not be accommodated. Other forms of discrimination are also prohibited under federal law. Some fed- eral prohibitions may extend to state and local government entities. States may also have their own antidiscrimination laws. Some liability protections will not applyâeven during emergenciesâto acts of dis- crimination. Specific limitations on liability or indemnity protections focused on willful or wanton misconduct should be interpreted to include unlawful acts of discrimination. OPERATIONAL IMPLEMENTATION OF CRISIS STANDARDS OF CARE Clinical Care in Disasters Disaster events will be marked by a sudden or gradual increase in demand for healthcare services and a related decrease in the supply of resources available to provide such care. This will result in a healthcare- sector response that requires implementation of a variety of âsurge ca- pacityâ strategies that include steps taken to reduce demand for care (e.g., the implementation of community-based triage capabilities and risk communication about when to seek care) and the augmentation of ambu- latory care capacity in addition to better described inpatient care strate- gies (Hick et al., 2004; Kaji et al., 2006; Barbisch and Koenig, 2006; Davis et al., 2005; Kelen et al., 2006, 2009; California Department of Public Health, 2008 ; Hanfling, 2006). Therefore, all healthcare enti- tiesânot just hospitalsâshould have plans to provide crisis care. Outpa- 8 The Age Discrimination Act of 1975, 42 U.S.C. Â§Â§6101-6107 (1975). 9 The Americans with Disabilities Act: Allocation of Scarce Medical Resources During a Pandemic, Title 42 U.S.C. Â§Â§ 504 (April 21, 2006).
52 CRISIS STANDARDS OF CARE GUIDANCE tient facilities (and community-based clinics, nursing homes, primary care, etc.) may use strategies modified from hospital guidance. EMS agencies may elect to use sample strategies as outlined below or develop system-specific responses. A number of strategies can be used to bolster the supply of key re- sources (i.e., space to deliver care, clinical staffing availability, and the availability of key supplies) (Hick et al., 2006; Kaji et al., 2006; Hick et al., 2009). Most likely the crisis will occur over a spectrum of supply and demand spikes, suggesting that a continuum of care will be in place over the course of any disaster response. It may be helpful to consider that surge capacity following a mass casualty incident falls into three basic categories, depending on the magnitude of the event: conventional, con- tingency, and crisis surge capacity (Box 2). Note that the same event may result in conventional care at a major trauma center, but crisis care at a smaller, rural facility. Conventional, contingency, and crisis care represent a continuum of patient care delivered during a disaster event. As the imbalance increases between resource availability and demand, health careâemblematic of the healthcare system as a wholeâ maximizes conventional capacity, then moves into contingency, and, once maximized, moves finally into BOX 2 Conventional, Contingency, and Crisis Capacity Conventional capacityâThe spaces, staff, and supplies used are consistent with daily practices within the institution. These spaces and practices are used during a major mass casualty incident that triggers activation of the facility emergency operations plan. Contingency capacityâThe spaces, staff, and supplies used are not consis- tent with daily practices, but provide care that is functionally equivalent to usual patient care practices. These spaces or practices may be used tem- porarily during a major mass casualty incident or on a more sustained basis during a disaster (when the demands of the incident exceed community re- sources). Crisis capacityâAdaptive spaces, staff, and supplies are not consistent with usual standards of care, but provide sufficiency of care in the setting of a catastrophic disaster (i.e., provide the best possible care to patients given the circumstances and resources available). Crisis capacity activation con- stitutes a significant adjustment to standards of care (Hick et al., 2009).
LETTER REPORT 53 crisis capacity. Concurrent with this transition along a surge capacity continuum is the realization that the standard of care will shift. This oc- curs primarily as a result of the growing scarcity of human and material resources needed to treat, transport, and provide patient care. The goal of the healthcare agency or facility is to return as quickly as possible to conventional care by requesting resources or transferring patients out of the area, drawing on the resources of partner or coalition hospitals and the health system as a whole. Along the span from conventional to crisis care, healthcare facilities should attempt to minimize changes that sig- nificantly impact patient outcomes by changing work practices in order to focus resources on patient care (Phillips and Knebel, 2007; ANA, 2008; Gebbie et al., 2009) (Figure 1). FIGURE 1 Continuum of incident care and implications for standards of care. NOTE: Post anesthesia care unit (PACU); intensive care unity (ICU) a Unless temporary, requires state empowerment, clinical guidance, and protec- tion for triage decisions and authorization for alternate care sites/techniques. Once situational awareness achieved, triage decisions should be as systematic and integrated into institutional process, review, and documentation as possible. b Institutions consider impact on the community of resource use (consider âgreat- est goodâ versus individual patient needs â e.g., conserve resources when possi- ble), but patient-centered decision making is still the focus. c Institutions (and providers) must make triage decisions balancing the availabil- ity of resources to others and the individual patientâs needs â shift to commu- nity-centered decision-making. SOURCES: Adapted from Hick et al. (2009); Wynia (2009).
54 CRISIS STANDARDS OF CARE GUIDANCE Catastrophic events will have an impact on the entire healthcare de- livery âsystemâ and will affect response and delivery of care that occurs in the home, community, hospitals, primary care offices, and long-term care facilities. A number of strategies can be implemented along this continuum of care delivery to reduce the likelihood that standards of care will change in a disaster situation. These include steps taken to substi- tute, conserve, adapt, and reuse critical resources, including the way staff are used in delivering care. All these steps should be attempted prior to the reallocation of critical resources in short supply (Tables 3 and 4). Every attempt must be made to maintain usual practices and the expected standard of care and patient safety (Rubinson et al., 2008; Minnesota Department of Health, 2008). TABLE 3 Sample Strategies to Address Resource Shortages Conventional Contingency Crisis Capacity Capacity Capacity Prepare Stockpile supplies used Substitute Equivalent medica- tions used (narcotic substitution) Conserve Oxygen flow rates Oxygen only for Oxygen only for titrated to minimum saturations < 90% respiratory failure required, discontin- ued for saturations > 95% Adapt Anesthesia machine Bag valve manual for ventilation mechanical ventila- tion Reuse Reuse cervical collars Reuse nasogastric Reuse invasive lines after surface disinfec- tubes and ventilator after appropriate ster- tion circuits after appro- ilization priate disinfection Reallocate Reallocate oxygen Reallocate ventila- saturation monitors, tors to those with cardiac monitors, the best chance of a only to those with good outcome critical illness SOURCE: Adapted from Hick et al. (2009).
LETTER REPORT 55 TABLE 4 Sample Strategies for Emergency Medical Services (EMS) Agencies to Address Resource Shortages EMS Agency Crisis: Implement Resources Contingency Changes Contingency Changes Plus: Dispatch Assign single agency Assign EMS only to life- responses, use medical threatening calls by prede- priority dispatch to termined criteria, no re- decline services to select sponse to cardiopulmonary calls resuscitation-in-progress calls, questions may be altered to receive limited critical information from caller Staffing Adjust shift length and One medical provider per staffing patterns unit plus driver Response âBatchâ calls (multiple No resuscitation on car- patients transported), diac arrest calls, decline closest hospital destina- service to noncritical, tion nonvulnerable patients and to critical patients with little to no chance of survival Broadening surge capacity must incorporate the full spectrum of pa- tient care delivery capabilities in a disaster-impacted community. This includes planning for extension of hospital-like services in an unregu- lated, non-healthcare setting. Examples of this include the establishment of Federal Medical Stations (FMSs) during the responses to the multiple Florida hurricanes in summer 2004, Hurricanes Katrina and Rita in 2005, and Hurricanes Gustav and Ike in 2008 (HHS, 2009). The initial con- cepts for such planning came from work conducted for the U.S. Army Soldier Biological Chemical Command in the late 1990s. These efforts focused on a combination of out-of-hospital capabilities divided between Neighborhood Emergency Help Centers (NEHCs) and Acute Care Cen- ters (ACCs) (Church, 2001, 2001b; Skidmore et al., May 2003; AHRQ, December 2004; Hamilton et al., 2009a; Hamilton et al., 2009b; Gavagan et al., 2006). The NEHC is intended to function as a community care station that provides a combination of functions, including victim triage, and serves as a distribution point for medical countermeasures. The ACC, similar to
56 CRISIS STANDARDS OF CARE GUIDANCE the FMS concept, serves as an out-of-hospital medical treatment facility for patients requiring a lower acuity level of care than that supported in a hospital critical care setting, but not well enough to be managed at home. Pandemic influenza planning has galvanized many communities to adopt such an approach to surge capacity planning, largely based on this theo- retical framework (Cinti et al., 2008). The components of this alternate care system are built around a stratification of care model, with emphasis on the use of triage algorithms that prioritize use of community-based services for selective patient care delivery that might otherwise be man- aged under non-disaster circumstances in the hospital setting. The com- mittee has made the assumption that the delivery of care in an unregulated environment would be construed as an alteration to the exist- ing standard of care. Yet such an approach may be necessary in order to prevent collapse of overburdened hospitals responding to a surge event. Even absent the threat of collapse, in some circumstances (such as an infectious epidemic) it is possible that higher quality, safer care can be provided outside the usual venues for most patients. In such conditions, a decision to relocate most care from hospital emergency departments to alternate care facilities would comprise a change in the usual standard of care, but superior quality compared to attempting to maintain ordinary use of the usual facilities. Disaster Mental Health Crisis Standards of Care In major disaster and emergencies, there will also be a surge of psy- chological casualties among those directly affected, including respond- ers, healthcare practitioners, and members of the population who have not experienced direct impact. Mass psychological casualties and mor- bidity will occur in those who experience an aggravation of a prior or concurrent mental health condition. New substantial burdens of clinical disorders, including PTSD, depression, and substance abuse may also arise among those with no prior history. Even in those with no formal disorder, there may be significant distress at a population level, resulting in unparalleled demands on the mental health system. The magnitude of new incidence disorder in the population has typi- cally ranged from 30 to 40 percent or more in those directly impacted, such as those who experienced personal losses (IOM, 2003; Galea et al., 2005). Although resilience may also be a result for some, the population- level impact of mass casualty incidents compared to other types of disas-
LETTER REPORT 57 ter will likely result in an substantive mental health burden on the nation during and after use of crisis standards of care requiring mental health interventions across varied âdisaster systems of careâ including the healthcare system, public and private mental health systems, schools, and coroner and other key systems at the community level (Schreiber, 2005). Therefore, it is necessary to use a mass casualty disaster mental health concept of operations to enable a crisis standard of disaster mental health care through the use of currently available evidence-based mental health rapid triage and incident management systems. For example, such systems used by the American Red Cross and Los Angeles (LA) County Emergency Medical Services Agency and those recommended by the National Biodefense Science Board Disaster Mental Health workgroup may serve as models (HHS, November 2008). The latter system, known as âPsySTART,â provides for rational allocation and alignment of lim- ited acute- and response-phase mental health assets to those with greatest evidence-based risks and needs in a phased, sequential manner so that those in need are matched to resources in the most timely fashion during response and recovery (Thienkrua et al., 2006). In the Los Angeles County Emergency Medical Services agency pilot project, for example, Los Angelesâs network of 14 Disaster Resource Center Hospitals (Level 1 trauma centers), the Department of Mental Health, and other key âdis- aster systems of careâ collect and are able to share triage information for near real-time situational awareness and a âcommon operating picture.â This information guides prioritization of crisis intervention at the hospi- tals and facilitates mutual aid across NIMS levels. Those with the great- est triaged needs are matched to available care until all those who are at risk and desire services can be further assessed and linked in the most timely manner to definitive care (Schreiber, 2005). There is now evi- dence that certain types of psychological interventions are the treatments of choice for conditions such as PTSD that are a frequent result from dis- asters, and the triage system allows for faster matching of the high-risk subset to appropriate and timely care (IOM, 2007). Palliative Care Planning for Crisis Standards of Care The provision of palliative care in the context of a disaster with scarce resources is a relatively new component of disaster planning. The goal of palliative care is to prevent and ease suffering and to offer pa- tients and their families the best possible quality of life at any stage of a
58 CRISIS STANDARDS OF CARE GUIDANCE serious or life-threatening illness and is not dependent on prognosis. It can also be provided at the same time as curative and life-prolonging treatment. Although the primary goal of a coordinated response to a disaster in- cident should be to maximize the numbers of lives saved, a practical plan also must provide the greatest comfort for those who will live for awhile before dying as a result of the incident (Holt, 2008). Triage and treatment practices that focus on maximizing the number of lives saved means that during a crisis, some people who might be successfully treated or cured under normal circumstances will die. During a crisis, palliative care would provide aggressive treatment of symptoms, such as pain and shortness of breath. In addition, triage to palliative care should allow for the fact that the initial prognosis for some patients will change, whether by virtue of their doing better than expected or by additional treatment resources becoming available. Identifying transition points in the condition of patients helps the pa- tient, family, and healthcare providers prepare for the final stage of life. A transition point can be defined as an event in the trajectory of an ill- ness that moves the patient closer to death. For example, a patient with chronic obstructive pulmonary disease may have no change in her condi- tion until she gets influenza and never fully recovers; for that patient, contracting influenza is a transition point in her condition (Berry and Matzo, 2004). Prognostication, aided by a risk index or scale, enables healthcare practitioners to plan clinical strategies during a crisis situation. These tools may be helpful in determining whether a patientâs illness has reached a terminal phase (Box 3) (Matzo, 2004). Providing a treatment category of âpalliative careâ for those not likely to survive will be an important service option for responders and triage officers. Acknowledging that a patient is not likely to survive typi- cally leads to discussions regarding the goals of care, appropriateness of interventions, and efforts to help the patient and family begin to say good-bye (Matzo, 2004). When resources are scarce, planners can make available alternative means of palliative care delivery and treatment. Planners should: â¢ Develop evacuation plans for existing and new palliative care patients; â¢ Develop a community response plan, staffing plans, and training programs for first responders and other relevant medical person- nel;
LETTER REPORT 59 â¢ Establish transparent, community-based, and explicit triage crite- ria for casualties not likely to survive; â¢ Develop a community education program to prepare the public; â¢ Stockpile needed palliative care medications and supplies (Wil- kinson and Matzo, 2006); and â¢ Participate in disaster planning, response and recovery training, and public education (Holt, 2008). BOX 3 Palliative Care Triage Tools Flacker Mortality Score: Flacker and Kiely developed a model for identifying factors associated with one-year mortality (the probability of death within the next year) by conducting a retrospective cohort study using Minimum Data Set (MDS) information from residents in a 725-bed, long-term care fa- cility (Flacker and Kiely, 1998). The Flacker Mortality Score instrument is the risk-assessment scale developed from those findings. It is used in con- junction with MDS data collected using the standard Resident Assessment Instrument and is applicable to elders living in long-term care facilities (Matzo, 2004; CMS, 2002). Risk Index for Older Adults: The Risk Index for Older Adults establishes point scores for several risk factors associated with death within one year of hospital discharge and allows a clinician to evaluate a patientâs risk of death accordingly. The point system is based on a study of 2,922 patients dis- charged from an acute care hospital (Walter et al., 2001). The researchers concluded that, in predicting one-year mortality, this index performed better than other prognostic scales that focus only on coexisting illnesses or physiologic measures. It takes into consideration a cancer diagnosis and is applicable to hospitalized elders (Matzo, 2004). Mortality Risk Index: A recent study by Mitchell and colleagues identified factors associated with the 6-month mortality of nursing home residents di- agnosed with advanced dementia (Mitchell et al., 2004). The retrospective study of MDS data from 11,430 patients with advanced dementia admitted to nursing homes in New York and Michigan generated risk scores based on 12 MDS variables. The researchers concluded that these risk scores provided more accurate estimates of 6-month mortality than those derived from existing prognostic guidelines (Matzo, 2004).
60 CRISIS STANDARDS OF CARE GUIDANCE Crisis Standards of Care Indicators Resources that are likely to be scarce in a crisis care environment and may justify specific planning and tracking include: â¢ Ventilators and components â¢ Oxygen and oxygen delivery devices â¢ Vascular access devices â¢ Intensive care unit (ICU) beds â¢ Healthcare providers, particularly critical care, burn, and surgi- cal/anesthesia staff (nurses and physicians) and respiratory therapists â¢ Hospitals (due to infrastructure damage or compromise) â¢ Specialty medications or intravenous fluids (seda- tives/analgesics, specific antibiotics, antivirals, etc.) â¢ Vasopressors/inotropes â¢ Medical transportation Implementation of crisis standards of care first requires recognition of a resource shortfall or impending resource shortfall. However, good situational awareness and incident management can often forestall any requirement to adjust standards of care as patients can either be moved to areas with resources or resources can be brought in to ameliorate the shortage prior to significant consequences for the patient(s). The commit- tee recognizes that this is a particularly important issue for rural health- care facilities. This is facilitated by monitoring critical resources and evolving events (e.g., ICU bed availability, ventilator availability, and other external health system measures such as situational awareness of both illness and injury numbers and rates within the community, epi- demic curve modeling, etc.) for indicators of the need for additional re- sources or, if no resources are available and no adaptive strategies can be implemented, planning for crisis standards of care. If there is a âno- noticeâ event such as a major explosion, or indicators are not available (or adjustments are not made or not able to be made), trigger events may occur (Box 4). Indicators such as bed availability are tracked routinely by many hospital systems, and surveillance tools monitor other data streams to provide possible early clues to an evolving epidemic. In addition to
LETTER REPORT 61 BOX 4 Indicators and Triggers Indicatorâmeasurement or predictor that is used to recognize capacity and capability problems within the healthcare system, suggesting that crisis stan- dards of care may become necessary and requiring further analysis or system actions to prevent overload. Triggerâevidence of use of crisis standard-of-care practices that require an institutional, and often regional, response to ameliorate the situation. event-specific data tracking (e.g., ventilators), these indicators should be used where available to determine the âcushionâ within the healthcare system and its variability over time. Facility, local, and regional indicators should be developed to enable anticipation and management of an incident prior to resources being overwhelmed. When event information is not available before it occurs, a system should be in place to collect/share that information during an event. Indicators may also be needed in the out-patient, homecare, and other environments, but have not yet been described. The committee was unable to identify evidence that specific indicators have predictive value for intervention (Schultz and Koenig, 2006; David- son et al., 2006; McCarthy et al., 2006), thus, the indicators noted in this document represent expert opinion only, and should be the subject of further research. Due to variables in staffing, in-patient census, and sys- tem characteristics, there were no data points that qualified as âtriggersâ for automatic action absent a sudden overwhelming event that would not require indicators to recognize. The members did feel strongly, however, that waiting for hard âtriggerâ evidence of crisis care was inappropriate, and that the goal should be anticipation of resource shortages based on situational awareness (including tracking of indica- tors), with correction of the problem prior to crisis when possible. The numbers reflected in the table are examples only, as there is tremendous variability between regions (Table 5). For example, at the workshop hosted by the committee some panelists believed that one hospital on ambulance diversion should be an indicator, while others noted that mul- tiple hospitals were on diversion on a routine basis in their communities.
62 CRISIS STANDARDS OF CARE GUIDANCE TABLE 5 Possible Indicators for Crisis Capacitya Indicators Institution/Agency Region State Situational awareness indicators Overall hospital < 5% available or no < 5% < 5% bed availability available beds for >12 hours Intensive care None available < 5% regional < 5% state beds unit bed beds available available availability Ventilators < 5% available < 5% available < 5% available Divert status On divert > 12 hours > 50% EDs on > 50% EDs on divert divert Emergency 2 times usual medical services call volume Syndromic Will exceed capacity Will exceed Will exceed predictions capacity capacity Emergency > 12 hours department (ED) wait time Event-specific indicators Illness/injury incidence and severity Disaster > 1 area hospital > 2 major hospitals declaration Contingency Any hospital reporting Any hospital Any hospital care being reporting reporting provided and unable to rapidly address shortfall Resource- Notification by Notification by Notification by specific shortage supplier hospitals hospitals/suppliers (e.g., antibiotic, immuno globulin, oxygen, vaccine) Outpatient care Marked increase in appointment demand or unable to reach clinic due to call volume Staff illness rate > 10% > 10% > 10% School Not applicable > 20% > 20% absenteeism
LETTER REPORT 63 Indicators Institution/Agency Region State Disruption of Utility or system failure > 1 hospital > 5 hospitals facility or com- affected affected or critical munity infra- access hospital structure and affected function a The indicators in this table should be developed in relation to usual resources in the area and usage patternsânumbers are examples only. There was agreement with the panelist that 18 hospitals on divert during the severe heat wave in Chicago certainly met the qualification of âindicatorâ (Stein-Spencer, 2009). In addition, staff absenteeism is likely to affect rural facilities and services disproportionately more than larger urban facilities, and âindicatorâ thresholds for the impact of infrastruc- ture damage also will vary substantially. Despite the lack of specificity available to the committee, we describe opportunities for indicator cap- ture in the hopes that further study may allow better definition of mean- ingful thresholds that may have at least some applicability across different populations. In particular, the committee acknowledges that triggers to move to crisis standards of care will likely be different for rural versus urban regions of a state. Therefore, this issue needs to be considered when formulating crisis standards of care protocols for use in disaster situations. Trigger events revolve around changes to staff, space, and supplies that constitute a change in standard practices such that morbidity and mortality risks to the patient increase (i.e., to crisis standards of care). Trigger events do not necessarily require a state response. If the institu- tion rapidly receives victims from a bomb blast that result in temporary (hours) use of cots for stable patients, but is able to return to conven- tional operations quickly, the facility can manage this incident internally without the need for the declared crisis standards of care. However, most such incidents require engagement of other healthcare facilities to dis- tribute patients to hospitals with more adequate resources. An example is the 2003 Rhode Island nightclub fire, when manual ventilation of pa- tients was performed in hallways pending air evacuation to regional burn centers (Dacey, 2003). Only in the case that the trigger event(s) are un- able to be ameliorated by patient evacuation or resource acquisition is state action required to provide protections to providers who are now delivering care under crisis conditions. This may occur in catastrophic events causing significant infrastructure loss and impeding patient trans-
64 CRISIS STANDARDS OF CARE GUIDANCE port (major hurricane or earthquake) or an epidemic (e.g., pandemic) that affects all institutions. Trigger points are only reached when the institutional surge capacity cannot accommodate the demand through conventional or contingency responses that do not require an adjusted standard of care (Table 6). Trigger points and actions taken when they occur can be easily incorpo- rated into job action sheets or surge capacity templates used at a hospital (e.g., âif providing cot-based care, hospital must notify Regional Medical Coordination Center (RMCC) by calling [555-555-5555]â). Regional personnel monitoring indicators and triggers must also have easy, intui- tive, scripted responses to a notification. Some regions may use categori- cal systems, but these require significant training and maintenance to be effective and understood, and are best used in well-developed, metropoli- tan systems (Sandrock, 2009). TABLE 6 Possible Triggers for Adjusting Standards of Care Category Trigger Space/structure Non-patient care locations used for patient care (e.g., cot- based care, care in lobby areas) or specific space resources overwhelmed (operating rooms) and delay presents a sig- nificant risk of morbidity or mortality; or disrupted or un- safe facility infrastructure (damage, systems failure) Staff Specialty staff unavailable in timely manner to provide or adequately supervise care (pediatric, burn, surgery, critical care) even after call back procedures have been imple- mented Supply Supplies absent or unable to substitute, leading to risk to patient of morbidity (including untreated pain) or mortality (e.g., absence of available ventilators, lack of specific anti- biotics)
LETTER REPORT 65 Crisis Standards of Care Implementation Criteria Prior to implementation of formal resource triage, the following con- ditions must be met or in process (Devereaux et al., 2008b): â¢ Identification of critically limited resources and infrastructure â¢ Surge capacity fully employed within healthcare facility â¢ Maximal attempts at conservation, reuse, adaptation, and substi- tution performed â¢ Regional, state, and federal resource allocation insufficient to meet demand â¢ Patient transfer or resource importation not possible or will occur too late to consider bridging therapies â¢ Request for necessary resources made to local and regional health officials â¢ Declared state of emergency (or in process) Crisis Standards of Care Triage Triage occurs routinely in medicine, when resources are not evenly distributed or temporarily overwhelmed. Examples include transfer of a patient to a trauma or burn center because most hospitals do not special- ize in these types of care, or a mass casualty incident when priority must be assigned for diagnostic imaging or surgery. These decisions are gen- erally ad hoc, based on provider expertise, and have minimal effects on patient outcome. Thus standards of care are routinely adjusted to re- sources available to the provider without requiring a formal process or declarations. However, the situation in disasters is more complex, as ser- vices the hospital usually provide may not be available or not available at all due to demand, with severe consequences to the patient who does not receive these resources. Triage involves both an assessment of the patientâs condition and the available resources. Triage of patients may occur at three points over the course of patient care: (1) primary triageâtriage of patients at first con- tact with the medical system (dispatch, EMS, or emergency department, at which point patients are assigned an acuity level based on the severity of their illness/disease); (2) secondary triageâreevaluation of the pa- tientâs condition after initial medical care (this may occur at the scene of
66 CRISIS STANDARDS OF CARE GUIDANCE the disaster or at the hospital following EMS interventions or after initial interventions in the emergency department); and (3) tertiary triageâ reevaluation of the patientsâ response to treatment after further interven- tions that may continue during their hospital stay. This is the least prac- ticed, least well-defined and perhaps most ethically challenging type of triage since it might entail removing a life-sustaining resource from one patient in order to provide it to another who is more likely to survive. Such decisions will always be wrenching, regardless the degree of oneâs training and preparation. Making them in an ad hoc fashion, without careful clinical and ethical consideration and guidance, is extremely risky. Furthermore, triage is different during two distinct response phases: reactive triage and proactive triage (Table 7). Reactive triage involves the ad hoc decisions made by clinical or administrative personnel to an exigent circumstance to allocate available resources in the face of an un- anticipated shortfall. These decisions must be accountable to general principles of ethical resource allocation, but do not follow a structured, systematic process (University of Toronto, 2005; AMA, 1995; Powell et al., 2008). Situational awareness is not available (i.e., the clinician mak- ing the decision is not in a position to manage resources or understand the magnitude of the event). Examples would include triage of multiple victims of an explosion to limited operating rooms immediately follow- ing the detonation. The goal is to minimize reactive triage decisions and assure those that are made are based on expert clinical judgment and ethical criteria. TABLE 7 Characteristics of Reactive and Proactive Triage Reactive Proactive Incident type Early in event time frame; Later in no-notice often no-notice event (of- event or anticipated, ten static or short time often dynamic event line, e.g., earthquake, (e.g., pandemic influ- bombing) enza) Incident management No (full implementation Yes implemented fully? is transition point to pro- active) Situational awareness Poor Good Resource availability Extremely dynamic (over Relatively static
LETTER REPORT 67 Reactive Proactive hours) Resource shortfall(s) Stabilization care through Definitive care, select definitive treatment medications or thera- pies Dominant triage Primary, secondary Tertiary Most likely resource Operative care (may not Mechanical ventila- triaged be able to provide any tion/ critical care operative care if massive (improvised nuclear event), diagnostic imag- device is an exception ing, fluid resuscitation due to delayed radiation illness) Triage decision maker Triage officer(s) on initial Triage team assessment Triage decision basis Clinical assessment Clinical plus diagnos- tics (decision tool) Decision making Unstructured, ad hoc Structured Regional and state No Yes guidance and legal protections Regional partner Available Unavailable (usually) assistance Proactive triage involves systematic decisions made by clinical or administrative personnel to a situation requiring resource triage where situational awareness is available and the decision-making is accountable to the incident management process. Examples would include prioritiz- ing patients for evacuation from a facility and allocation of limited venti- lators in a pandemic. Guidelines are available for some of these situations. For situations that lack specific guidance, appropriate subject- matter experts should weigh available information and make decisions consistent with principles of ethical resource allocation.
68 CRISIS STANDARDS OF CARE GUIDANCE Prerequisite Command, Control, and Coordination Elements The implementation of crisis standards of care and fair and equitable resource allocation requires attention to the core elements of incident management, including situational awareness, incident command, and adequate communication and coordination infrastructure and policies. Without this foundation, medical care will be inconsistent, and resources will not be optimally used (Hick et al., 2009). Situational Awareness Situational awareness will improve the ability to predict and recog- nize resource shortages and allocate fairly to minimize disparities. Each institution in coordination with community and institution partners should be actively engaged in gathering, interpreting, assessing, and sharing information. Healthcare systems can use multiple sources for information gathering and establish working partnerships prior to crisis events that are then used fully during the crisis. Information sources or areas for which information is gathered in- clude, but are not limited to: â¢ Media: television, print, radio, and the Internet; â¢ Environmental sources of information: reports regarding weather, air, and water quality, etc.; â¢ Federal communications; â¢ State and local/regional infrastructure: facility environment of care and community infrastructure (power, telecommunications, road systems, schools, etc.); â¢ Transportation: mass transit, air transport, port authorities, and information about EMS transportation capabilities, including ro- tor-wing and ground units; and â¢ Healthcare systems information: syndromic surveillance, epide- miological monitoring of illness and injury, national pharmacy data, 911 dispatch, call centers, poison control centers, HAvBED, local bed reporting systems, mortuary data, veterinary data, emergency department visits/status, and regional hospital operational and diversion status (AHRQ, 2005a).
LETTER REPORT 69 Consistent, timely, and two-way information sharing is essential. Es- tablished points of contact and means of contact should be exercised regularly. Incident Management: Consistency, Coordination, and Communications Incident management systems in the United States are based on a common framework called the National Incident Management System. The widely used Hospital Incident Response System is a NIMS- compliant incident management system modified for hospital applica- tions (FEMA, 2009a; California Emergency Medical Services Authority, 2007). All healthcare facilities and entities must have a well-practiced incident management system and understand their plans for notification, activation, mobilization of resources, and continuity of operations. Health and medical response is managed in the National Response Framework as outlined in Emergency Support Function (ESF) #8â Public Health and Medical Services (FEMA, 2009b; Courtney et al., 2009). At this time, ESF-8 does not have specific provisions for crisis standards of care. However, federal response partners should ensure the integration of relevant provisions. A system of a tiered response, ranging from healthcare management asset through federal responses, has been described by HHS and should be used by all hospitals and regional sys- tems and are a core part of catastrophic response planning (Devereaux et al., 2008a; Phillips and Knebel, 2007; Courtney et al., 2009). All healthcare systems must also understand how their incident man- agement system interacts with that of jurisdictional emergency manage- ment and any coalition hospital response partners, including the process for obtaining assistance during an emergency (Figure 2).
70 CRISIS STANDARDS OF CARE GUIDANCE FIGURE 2 Overview of relationships among agencies, committees, and groups NOTE: Depending on the organization of the state, the functional layout, details, and relationships among the units might vary.
LETTER REPORT 71 Local/Regional Healthcare Coalitions In many areas, regional healthcare coalitions exist that provide a common coordination point for hospital planning and response (Courtney et al., 2009; Phillips and Knebel, 2007; Hodge et al., 2009a). In certain environments, this coordination may be supplied by the state. Often, the coalition designates a Regional Medical Coordination Center (RMCC) function that coordinates hospital information and coordinates resource management during a major disaster (Burkle et al., 2007; Courtney et al., 2009; Phillips and Knebel, 2007). These coalitions may be within a ju- risdiction, represent an entire jurisdiction, or overlap several jurisdictions or even states. Coalitions are generally organized around functional medical referral areas, however, as noted by Courtney et al. (2009): The geographic boundaries of healthcare coalitions are highly variable, and the definition of community must remain flexible to incorporate local needs and realities. The essential feature is that every hospital in the chosen geographic area is included. In some places, the coalition may be composed of all hospitals and other members within a county or a city, while in others members may be from an entire state. In some small or low population density states, a single coalition may represent all hospi- tals and relevant partners in the entire state. In some large cities, the jurisdiction may be divided into [smaller] more manageable sub-municipal regions, so that a single city might have multiple coalitions. In many locations, coalitions cross jurisdictional borders and are not aligned with the normal geographic boundaries of all individual coalition members. Healthcare coalitions should be designed to provide added adminis- trative and logistical support to the many components of the health sys- tem that need to share limited resources or to transfer patients due to disaster situations. Notably, during a catastrophic disaster, reliance on the state or adjacent regions may become greater. Similar to traffic manage- ment or information technology networks, when one part of the system is overloaded, other parts of the system can help accommodate the load and maintain function. During a pandemic, limited or no âbufferâ is available due to the pervasive nature of the epidemic, and the coalition function
72 CRISIS STANDARDS OF CARE GUIDANCE becomes coordination of consistent care across its members, rather than diffusion of demand across the system. A system of tiered response, from individual healthcare institutions as part of healthcare coalitions, coali- tions as part of a jurisdiction(s) response, jurisdictional interface with the state, and the stateâs interaction with federal response, have been de- scribed and should be used by all hospitals and regional systems as a core part of catastrophic response planning (Barbera and McIntyre, 2007; Phillips and Knebel, 2007; Rubinson et al., 2008). Coalitions streamline and facilitate resource allocation and policy coordination in disasters. The coalition must be integrated with key stakeholder agencies within ESF-8, including the broader âhealth sys- temâ (which may include clinics, long-term care facilities, behavioral health, and specialty resources, e.g., dialysis) as well as local and re- gional public health entities, emergency management entities, and emer- gency medical services. Often, these entities cross jurisdictions and are best coordinated using a Multi-Agency Coordination (MAC) (National Wildfire Coordinating Group, 1994). If no coalition is present in an area, hospitals must still integrate with the emergency management response (Figure 3). The MAC is the basis for establishing situational awareness and pol- icy coordination across a given region, and incorporates data from the key participants, informing the decision-making process with regard to the transitions among conventional, contingency, and crisis care. It may also be delegated authority from participating agencies to manage scarce resources. The MAC and jurisdictional Emergency Operations Centers (EOCs) coordinate with the state EOC, though the degree of engagement and ability to make resource requests varies by state; emergency manag- ersâ assistance must be engaged to assure the stateâs system requirements are met by the MAC concept of operations. Some areas of the United States have very robust and strong regional healthcare and emergency response coordination mechanisms that may be the decision point for crisis standards of care policy and resource allocation, while others will rely on the state for these functions.
LETTER REPORT 73 FIGURE 3 HHS Medical Surge Capacity and Capability (MSCC) framework. NOTE: Emergency management program (EMP); emergency operations plan (EOP); public health (PH); emergency management (EM); healthcare organiza- tion (HCO); incident command system (ICS). SOURCE: Barbera and Macintyre (2007). Such coalition-building efforts can incorporate the presence of DoD military treatment facilities, of which there are more than 200 distributed on military bases across the United States. These facilities have assigned staff to attend to the emergency management requirements of their healthcare facilities, and most recently have designated a public health emergency officer on each of its bases to assist in the coordination of planning for a major public health emergency (Hachey, 2009). In addi- tion, the VHA, with more than 150 medical centers across the country (some of which serve in the role as federal coordinating centers for the National Disaster Medical System), has championed the importance of its emergency management efforts, including plans to manage critical resource shortages (HHS, 2008; Franco et al., 2007; Bierenbaum et al., 2009; Department of Veterans Affairs, 2009; Sharpe, 2009). Command- ers and directors of these facilities have authority to provide humanitar-
74 CRISIS STANDARDS OF CARE GUIDANCE ian care in an emergency, and are often involved in community-based planning efforts. State Coordination State coordination often occurs at the state EOC which is the recipi- ent of information provided from the local and regional levels via the local EOC, RMCC(s), and MAC centers. Based on the information pro- vided by the local and regional entities, the state EOC evaluates and processes resource requests. At the state level, resources should be allo- cated to regions in greatest need during a pervasive event, and guidance provided and emergency power actions taken as needed. This requires excellent ability to gather, coordinate, and communicate information in order to be effective. The state EOC is also the means for relaying infor- mation to the local level from neighboring states and the federal partners regarding situational awareness related to resource availability and con- ditions of medical practice in other regions. Coordination of care in a disaster event is of paramount importance to the successful mitigation and response effort. This is even more cru- cial in situations in which there may be a scarcity of resources available for providing care where the overriding state goal is to ensure a level of care across the state that is as consistent as possible. Social chaos and disruption may arise from public perceptions that one community or healthcare system is providing a different level of services than another. This failure to meet public expectations regarding the availability of fun- damental healthcare services has the likely effect of exacerbating public confusion during an already chaotic disaster event, while undermining confidence in those responsible for taking charge (Townsend, 2006; Danzig et al., 2007; McHugh et al., 2004). In addition, one of the fundamental tenets in delivery of healthcare services under crisis conditions is that every effort will be made to maximize delivery of care to a standard that meets community norms, until that is simply not possible. Without the sort of coordination that allows for the visibility of available resources and their location, this cannot occur. Patients cannot be denied resources just because the re- sources are exhausted in one area, when they are available nearby. Interstate coordination occurs at the state EOC during an event (via the governorâs office or designated agencies such as public health) in order to ensure coordination of resource-sharing agreements, information
LETTER REPORT 75 exchange, and consistent decision implementation related to standards of care. Before the event, such dialogue is the responsibility of the State Department of Health, though local health departments in major metro- politan areas may also need to open dialogue directly with border com- munities in other states to ensure common assumptions and frameworks. Recommendation 5: Ensure Intrastate and Interstate Consistency Between Neighboring Jurisdictions States, in partnership with the federal government and localities, should initiate communications and develop processes to ensure intrastate and interstate consistency in the implementation of crisis standards of care. Specific efforts are needed to ensure that De- partment of Defense, Veterans Health Administra- tion, and Indian Health Services medical facilities are integrated into planning and response efforts. Crisis Standards of Care Operations When crisis care becomes necessary, a threshold has been crossed requiring that the affected institution(s) either quickly address the situa- tion internally, or, more likely, appeal to partner facilities and agencies for assistance in either transferring patients to facilities with resources or bringing needed resources to the facility. If these strategies cannot be carried out, or if partner facilities are in the same situation (e.g., a pan- demic influenza scenario), then systematic implementation of crisis stan- dards of care at the state level may become necessary in order to codify and provide guidance for triage of life-sustaining interventions as well as to authorize care provided in non-traditional locations (alternate care fa- cilities). Because disaster incidents may have a wide-ranging impact on ser- vice delivery, a number of processes must occur, as described below. State Responsibilities The state has an obligation to ensure consistency of medical care to the highest degree possible when crisis care is being provided. Usual co- ordination and resource requests outlined above are used to minimize
76 CRISIS STANDARDS OF CARE GUIDANCE healthcare service disruption and/or to provide the most consistent level of care across the affected area and the state as a whole. When prolonged or widespread crisis care is necessary, the state should issue a declaration or invoke emergency powers empowering and protecting providers and agencies to take necessary actions to provide medical care and should accompany these declarations with clinical guidance, developed by the State Disaster Medical Advisory Committee (SDMAC), to provide a consistent basis for life-sustaining resource allocation decisions. Individ- ual hospitals and healthcare facilities should work through tactical mu- tual aid agreements with other local facilities and at the regional level to ameliorate conditions that might force crisis standards of care. When these strategies have been exhausted, healthcare facilities, working through local public health authorities, should request a State emergency declaration recognizing that crisis conditions are at hand, that a change in acceptable standards of care are required, and that crisis standards of care must be initiated. The SDMAC should be part of the planning process, as outlined in the section above on state planning, but also can be an important part of the response process, drawing on its expertise and that of other pre- identified subject-matter experts to address response-generated issues. Thus, the state, through its emergency powers, resource allocation, and provision of clinical guidance, attempts to âlevel the playing fieldâ at the state level, as well as provide legal protections for providers making difficult triage decisions and provide relief from usual regulations that might impede coping strategies such as alternate care facilities. Regional healthcare coalition data on the status of patient care deliv- ery and access to key resources should be reflected to the state level, where the state EOC synthesizes information. The state EOC will be an important broker of information gathered from across the state, as well as the initial source of relayed information made available from neighbor- ing states and the federal government. Regional Responsibilities Some hospital coalitions cover large metropolitan areas and thus, the Regional Medical Coordination Center acts as liaison between the state and its constituents. The RMCC may be an agency, such as public health, or a hospital or other facility designated by the system. The RMCC at- tempts to ensure regional medical care consistency and may do so by
LETTER REPORT 77 acting as a resource âclearinghouseâ between the healthcare facilities and emergency management and coordinating policy and information to meet regional needs. This may involve a Regional Disaster Medical Advisory Committee (RDMAC) or at least a medical advisor or coordinator with access to technical experts in the area, particularly in large metropolitan areas because the specific needs of the area may not be well addressed by state guidance. However, the regional guidance cannot be inconsistent with that of the state. Healthcare Facility Responsibilities Though this section will emphasize emergency and hospital-based care, all healthcare facilities should have plans to preserve the acute care and other critical elements of their disaster services through elimination of certain usual services and curtailment of others. Taking an approach that incorporates âengineered failureâ will ensure that those services that are absolutely essential will be maintained, at the expense of less press- ing needs (Hick et al., 2007; ICDRM, 2009). For example, the delivery of dialysis care to patients with end-stage renal disease may be priori- tized over out-patient elective surgery. A sample institutional process is outlined in Box 5 below. Clinical Care Committee The individual healthcare institution surge capacity plan should in- corporate the use of a âclinical care committeeâ that is composed of clinical and administrative leaders who can focus a hospital or hospital system approach to the allocation of scarce, life-saving resources (Phil- lips and Knebel, 2007; Hick and OâLaughlin, 2006; OâLaughlin and Hick, 2008). BOX 5 Sample Institutional Processa 1. Incident commander recognizes that systematic changes are or will be required to allocate scarce facility resources and that no regional re- sources are available to offset demand. 2. Incident commander activates clinical care committee (or designated members).
78 CRISIS STANDARDS OF CARE GUIDANCE 3. Planning chief gathers any guidelines, epidemiologic information, re- source information, and regional hospital information. 4. Clinical care committee reviews facility/regional situation and examines: a. Alternate care facilitiesâcan additional areas of the building or ex- ternal sites be used for patient care? (should be planned in ad- vance). b. Medical care adaptationsâ(e.g., use of non-invasive ventilation techniques, changes in medicine administration techniques, use of oral medications and fluids instead of intravenous, etc.). c. Changes in staff responsibilitiesâto allow specialized staff to redis- tribute workload (e.g., floor nurses provide basic patient care in the intensive care unit while critical care nurses âfloatâ and trouble- shoot) and/or incorporate other healthcare providers, lay providers, or family members where practical (Rubinson et al., 2008; Rubin- son et al., 2005). d. Regional challenges and strategies being used by members of the coalition (with ongoing coordination with the Regional Medical Co- ordination Center and, if used, the Regional Disaster Medical Advi- sory Committee). Develop strategies based on challengesâthe committee describes how resources at the facility (emergency department [ED] resources, beds, operating rooms, ventilators) will be allocated. (What level of severity will receive care? What tool or process will be used to make decisions when there are competing demands for the same resource?) 5. Committee summarizes strategies for next operational period and de- termines meeting and review cycles for subsequent periods (may in- volve conference calls or similar to avoid face-to-face meetings during a pandemic). 6. Incident commander approves committee strategies as part of incident action plan. Plan is operationalized. Public Information Officer commu- nicates updates to staff, patients, families, and the public. 7. Current in-patients, patients presenting to the hospital, and their family members are given verbal and printed information (ideally by the triage nurse in the ED, or for in-patients, by their primary nurse or physician) explaining the situation and, if necessary, explaining specific resources subject to triage or âtreatment trialsâ that may have to be ended in order to provide care to others with higher likelihood of benefit. A mechanism for responding to patient/family questions and concerns should also be detailed in the written guidance. 8. Security and behavioral health response plans should be implemented. 9. ED/out-patient screening of patients (and denial of service to patients either too sick or too well to benefit from evaluation/admission) based on guidance disseminated by the clinical care team is implemented. 10. Tertiary triage team (ideally NOT the physicians directly providing the patients care and ideally two critical care physicians of equal ârankâ in the institution) considers situations in which there are competing patient demands for a scare resource. The resource should be assigned as fol- lows. a. When two patients have essentially equal claim to the resource, a âfirst-come, first-servedâ policy should be used.
LETTER REPORT 79 b. When, according to guidelines or the triage teamâs clinical experi- ence, the claim to the resource is clearly not equal, the patient with a more favorable prognosis/prediction shall receive the re- source. c. The triage team should ask for and receive whatever patient in- formation in necessary to make a decision, but should NOT con- sider subjective assessments of the quality of the patientâs life or value to society and, in fact, should ideally be blinded to such in- formation when possible. 11. The in-patient unit leader (under HICS, or comparable position) should be appointed to make final bed assignments and changes and commu- nicate triage decisions to the clinical team. This individual should have access to real-time-in-patient and out-patient system status and when needed, patient clinical information. 12. Whenever a decision is made to reallocate a ventilator or similar critical resource, the treating physician and family should be provided with the grounds for the decision (which should be documented for the record at the facility), and a rapid appeals process if there is additional or new in- formation that the family or treating physician(s) feel would affect the decision. 13. Transition care plans should assure the comfort and dignity of those who are no longer receiving full treatment modalities and assure sup- port for the family and care providers. a Adapted from Hick et al. (2007). A clinical care committee is activated by the facility incident com- mander when the facility is practicing contingency or crisis care due to factors that are not readily reversible. This committee is responsible for making prioritization decisions about the use of resources at the relevant healthcare institution (e.g., hospital, primary care, EMS agency, and oth- ers). Some health systems own many facilities in an area, and may have a central committee, with a liaison at each hospital to prioritize within their system. This committee will also inform the institutionâs incident com- mander and planning chief about capabilities, recommendations, and re- quirements for providing care under such conditions. Members should include institution administrators, attorneys, a nursing supervisor, a res- piratory care supervisor, ethicists, a community representative, and rep- resentatives from relevant clinical departments, though response configurations may be much smaller and tailored to incident needs by the facility incident commander (Hick and OâLaughlin, 2006). Although the institutionâs clinical care committeeâs deliberations will be institution focused, the institutional incident commander or planning chief should
80 CRISIS STANDARDS OF CARE GUIDANCE have some situational awareness of what is occurring outside the institu- tionâin the rest of the health system (e.g., resource demand, disease bur- den, etc.). In addition, the institutionâs clinical care committee must be able to allocate critically limited life-saving interventions. The VHA refers in its guidance to this group as the âScarce Resource Allocationâ committee. The IOM committee prefers âClinical Care Committeeâ due to the broader responsibilities this group may take on, but understands that this group may be called different names and achieve the same function (VHA, 2008, 2009). The clinical care committee chair, in conjunction with the incident command, must maintain active liaison with the RMCC (and RDMAC, if activated) and as needed with the SDMAC to maintain situational aware- ness of area resources, challenges, strategies, and guidance. Triage team In some cases, critical life-sustaining resources such as ventilators may have to be triaged in a proactive, systematic fashion consistent with state guidance. In this case, the clinical care committee should appoint or ensure access to a triage team, which will use decision tools appropriate to the event and resource being triaged to make allocation decisions (Devereaux et al., 2008b; AHRQ, 2005b; Hick et al., 2007; Hick et al., 2004; OâLaughlin and Hick, 2008). The patientâs bedside clinician should not be the triage decision maker in order to remain an advocate for the patient. The triage team may be located at the hospital or may be a regional function, depending on the preference of the hospital coalition, and its composition may vary somewhat depending on resources available, but generally should be no less than two experienced clinicians (AHRQ, 2005b; Rubinson, 2008b; Tabery and Mackett, 2008). At a regional level, the triage team can pro- vide advice and also help smaller hospitals, and other appropriate com- ponents of the health system, to determine the priorities for rural patient transfers and provide advice regarding current status of critical care at larger facilities. Documentation is placed into the patientâs record regard- ing any decisions made by the triage team, including the situation and specific justifications. The triage teamâs recommendations are then car- ried out by a nursing supervisor or other designee of the institution, and
LETTER REPORT 81 are reviewed by the clinical care committee on a daily basis for quality and process assurance. The triage teamâs decisions may be reviewed more expediently in two cases: â¢ Clinical reviewâif the patientâs clinical condition has changed significantly since data were supplied to the team, the patientâs provider can request a reassessment prior to discontinuation of treatment that the triage team will consider. â¢ Process reviewâif there are concerns raised about an unjust or inappropriate application of the triage process, the clinical care committee chair will review the decision-making process. This review may occur before or after withdrawal of treatment, de- pending on the complaint and when it is received, and a finding will be issued, including communication to a regional or state ethical workgroup or board, depending on the stateâs structure (VHA, 2008, 2009; DeBruin et al., January 2009). Decision Tools and Resource Use Guidance Decision tools are used by the triage team as a basis for, or to at least inform, triage decisions. Triage decision tools must be regionally consis- tent in a disaster event, highlighting the importance of the state as a source of guidance when possible. The healthcare coalition RMCC (or RDMAC, if established) can serve as the coordinator of policy, informa- tion, and process improvement. Intrastate consistency should be moni- tored by the SDMAC. The state department of health or governor should assure that the guidance they approve is consistent across state borders by consultation with adjacent state health departments (and EOCs during an event). State guidance can also offer additional information about maximiz- ing availability of the scarce resource to minimize impact on patients that may be specific to a resource or broader (Minnesota Department of Health, 2008). Decision tools and guidance should not be construed as to prevent reasonable consideration of other clinical factors that may weight a decision to provide or reallocate a scarce resource, but are issued to provide consistency and as much weight of evidence as possible to the decision-making process. This discussion provides a cross-section of
82 CRISIS STANDARDS OF CARE GUIDANCE available information that was the best available to the committee at the time of writing. Although the most examined decision tools revolve around mechani- cal ventilation, guidance is also available for other core medical care components (medications, oxygen, etc.) and limited guidance is available for specific other resources (see Box 6) (Minnesota Department of Health, 2008). Little guidance is available for the dispatch, EMS, home care, long-term care, and ambulatory care environments as part of the overall health system within a community. Though much of the core component guidance does apply, agencies and entities should examine potential scarce resources and outline coping strategies using base prin- ciples similar to those for hospital environments (Rubinson et al., 2008; ANA, 2008). None of the current systems or guidance was designed for pediatrics or other medical special needs patients, and this gap should be addressed by appropriate specialty expert groups. Finally, the needs of other vulnerable populations should also be kept in mind to ensure fair- ness in the system that is developed. BOX 6 Select Specific Resource Issues Note: synopsis and examples are not comprehensive, but suggest areas for state guidance and expert working group efforts. Blood productsâThe American Association of Blood Banks can facilitate blood delivery rapidly to areas affected by disasters. However, in the immediate af- termath of a catastrophe, local shortages may occur. Hospital blood banks and their suppliers should determine triage plans ahead of time, altering in- dications for transfusion and capping use of products where necessary (Schmidt, 2002; Ontario Ministry of Health and Long-term Care, 2008). Elective surgery triageâAssessment of surgical schedules during an event may require a cancellation of the procedures that are most likely to require post- operative critical care and may assist in opening/maintaining capacity. De- termining which procedures may be safely deferred and for how long is important. Ontarioâs and Utahâs plans both include assessments of elective surgeries (Ontario Ministry of Health and Long-term Care, 2008; The Utah Hospitals and Health Systems Association, January 2009). Trauma careaâCatastrophic disasters may produce overwhelming numbers of trauma patients. Most disasters do not overwhelm surgical services, but con- tingency (conducting temporizing surgical procedures, performing bedside procedures, limiting interventions to patients with good outcome and single- system trauma) and crisis (providing no interventions in the operating room in favor of controlling hemorrhage in multiple patients and performing chest decompression and other limited life and limb-saving interventions) plans
LETTER REPORT 83 should be understood by the surgical and support staff (Eastridge et al., 2006; Propper et al., 2009). RadiationaâGuidelines for triage of radiation incident victims are widely available, though literature and predictive instruments are scant for victims of combined trauma and radiation injury (Waselenko et al., 2004; Fliedner et al., 2001; REMM, 2009; IAEA, 2009). Guidance for response to an improvised nuclear device detonation with more detailed guidance for health and medical re- sponse is to be published in 2010 (DHS, January 2009). Burn careaâCare of multiple burn victims requires exceptional amounts of anal- gesia, intravenous fluids, and burn dressings. However, these may be inex- pensively and easily stockpiled. In mass casualty events, an age/percentage burn table has been published as an adjunct for triage decisions (Saffle et al., 2005). Providing care to many victims with limited staff and burn unit space must be addressed in planning (Posner et al., 2003). CancerâDuring a disaster, continued comfort and care appropriate to the re- sources available should be ensured. Particular emphasis for palliative care needs should be considered in this population. Ontario has published basic guidance to assist with determining priorities for this special population (On- tario Ministry of Health and Long-term Care, 2008). Renal replacementâAvailability of renal replacement therapy may be extremely limited after a disaster due to competing demands for dialysis from incident- related patients or unsafe water supply. Deferral of usual dialysis schedules and indicators may have to occur, and other measures instituted. Ontario has published basic guidance to assist with determining priorities for this special population (Ontario Ministry of Health and Long-term Care, 2008). VaccinesâPandemic and other vaccines may initially be in short supply, and pri- orities may need to be established. Liability and mass vaccination logistic is- sues may have to be addressed. Guidance for administration will come from the Centers for Disease Control and Prevention, or CDC (e.g., Advisory Committee on Immunization Practiceâs recommendations for 2009 H1N1 vaccine priority groups). However, further splitting of priority groups may have to occur at the state and even institutional level depending on supply (CDC, 2009c). Antiviral medicationsâBy example, some medications in relative shortage may be targeted to those at highest risk, those most likely to benefit, or use reduced to prevent evolution of resistance. Limited treatment of 2009 H1N1 with anti- viral medication recommendations from the CDC are an example of this form of triage of resources and must be adopted and circulated by the state and voluntarily implemented by providers (CDC, 2009d). a Regional (may be interstate or intrastate) planning should provide for hospitalization of the most critical patients at appropriate centers, with diffusion of less critical victims to commu- nity hospitals and transfers used when possible.
84 CRISIS STANDARDS OF CARE GUIDANCE Some literature is available to predict in-hospital requirements for critical care and to make general mortality predictions, and these may be useful when determining whether to hospitalize patients, send them home, or transfer them to an alternate care setting. However, these scores are not as useful in comparative prediction of mortality and are not pre- cise, thus, the committee cannot recommend specific prognostic tools based on clinical assessment at this time (Talmor et al., 2007; Challen et al., 2007). A concept originating in military triage which, though not a tool per se, may be used to weigh resource commitment is âminimum qualifica- tions for survivalâ (MQS), which is the idea that one critically ill patient may consume the resources that could save several other patients, and may have their resource allocation reduced or withdrawn by establishing a ceiling on resources expended on a single patient (Christian et al., 2006). As an example, in military mass casualty experience described by Propper, 8 percent of patients consumed 43 percent of blood products used. In situations of resource shortages where the resource is titrated or dosed (medications, IV fluids, blood products, but not ventilators), the clinical care committee may wish to establish a ceiling on the amount of resources required in addition to changes to indications for treatment (Propper et al., 2009; Beekley et al., 2007; Eastridge et al., 2006; AMA, 2007). Triage of limited mechanical ventilators may have to occur in perva- sive events when no alternatives are available and temporizing therapies (e.g., bag-valve ventilation) cannot be implemented. Using the CDCâs Flu Surge 2.0 models for a severe pandemic (and assuming an 8-week pandemic wave, which is likely more compressed than what will be ob- served) suggests that at a busy, urban Level 1 trauma center, approxi- mately 0.62 patients per hour may present during the peak weeks of the first wave with respiratory failure, necessitating ongoing monitoring and triage of resources to those with the best possible chance of survival (CDC, 2006). Those triaged to receive mechanical ventilation thus re- ceive a therapeutic trial of ventilation. Predictions are applied to all ICU patients, not just incident-related patients. If the patient does not respond to an adequate trial, worsens, or another patient with a significantly bet- ter chance of benefit presents, the trial may be ended and the resource reallocated (Devereaux et al., 2008b; Hick and OâLaughlin, 2006; Chris- tian et al., 2006; Hick et al., 2007; VHA, 2008). Notably, the âtherapeu- tic trialâ may require days, as young, healthy individuals with severe pneumonia or respiratory distress syndrome may take many days to re-
LETTER REPORT 85 spond to treatment. All patients should be reassessed at least every 24 hours, however. As triage continues over days to weeks, the trend toward healthier patients on the available ventilators will likely reduce the de- gree of ventilator turnover compared to early in the triage process. The impact of such decisions on providers and family, not to men- tion patients, cannot be understated and requires careful management of expectations on hospital admission as well as support and thoughtful transition plans as care is withdrawn to assure patient comfort and con- tinued supportive care to the extent possible. Due to the unique characteristics of ventilators (limited, expensive, technically complex resources that provides life-saving intervention and cannot be shared or titrated), much of the current decision tool efforts have centered around ventilator triage and critical care triage (Devereaux et al., 2008b; Christian et al., 2006; Hick et al., 2007; Hick and OâLaughlin, 2006). The decision tools generally are based on prognosis of the acute illness and any severe, underlying diseases that drastically limit life expectancy. Guidelines for ventilator triage have already been adopted by several states and are in consideration by many others (Minnesota Department of Health, August 2008; The Utah Hospitals and Health Systems Associa- tion, January 2009; Colorado Department of Public Health and Environ- ment, July 2009). These guidelines are generally based on several articles published in the past few years. Thus far, the Sequential Organ Failure Assessment (SOFA) score is used by all proposed systems as a core component (Vincent et al., 1996; Moreno et al., 1999; Vincent et al., 1998; Peres Bota et al., 2002; Pettila et al., 2002). SOFA uses clinical and some simple laboratory variables (PaO2, bilirubin, creatinine) to pre- dict outcome by assessing degree of organ system dysfunction and is one of the least complex and most predictive available metrics for prognosis prediction in critical care. Some systems consider other factors such as expected duration of ventilation, underlying diseases, or duration of benefit (Minnesota De- partment of Health, August 2008; Devereaux et al., 2008b). Others in- corporate exclusion criteria to varying degrees (VHA, 2008, 2009; The Utah Hospitals and Health Systems Association, January 2009; Devereaux et al., 2008b; White et al., 2009; Christian et al., 2006; Hick and OâLaughlin, 2006). Incorporation of age as a specific variable has been proposed by one author (White et al., 2009). Though the âfair inningsâ argument to allow ventilator allocation to younger patients is attractive at face value, age is not a medically useful
86 CRISIS STANDARDS OF CARE GUIDANCE predictor of outcome; use of age as a criterion in and of itself also raises ethical and legal concerns. Until society determines through public en- gagement that age-based triage (or other non-medical criteria such as functional capacity) is appropriate and defines an appropriate range, the committee recommends avoiding age-based criteria. Furthermore, the committee cautions against the prima facie use of DNR status as a deci- sion tool, as underlying, life-limiting medical conditions should primarily be used as triage criteria rather than the fact that the patient has provided an advance directive. The committee also notes that, although SOFA is useful to assign retrospective survival prediction, it was not designed as a prospective predictor of survival, and thus, differences in a single point on the SOFA scale are of unknown clinical significance for prediction of outcome. This should be considered, particularly when attempting any modifica- tion or extension of the SOFA scale beyond its initial construct that may further compromise its predictive value and when using systems that would assign or discontinue a resource based on a single-point change in the SOFA score. SOFA has not been validated on a pediatric population. Although the principles of increasing mortality with increasing multi-organ dysfunc- tion do apply, caution must be exercised when using SOFA to make any- thing but broad comparisons. Currently, predictive scoring systems for pediatrics (e.g. PRISM, P-MODS) are being considered for use in per- forming pediatric triage for ventilator allocation (Pollack et al., 1988; Graciano et al., 2005). However, at least one of these tools, PRISM, in- volves the evaluation of additional laboratory variables than those re- quired for SOFA, and therefore might be more difficult to apply under conditions of crisis care. The other tool, P-MODS, evaluates parameters different than those used in SOFA scoring. The committee concludes that urgent recommendations from pediatric disaster groups and research are needed to address this gap. Adopters of decision tools should understand their limitations and scope and communicate issues of uncertainty to the triage team members. The only process and triage system that is the output of an expert, specialty society working group with broad stakeholder input at this time is that of the American College of Chest Physicians (ACCP) (Devereaux et al., 2008b). The advantage of the ACCP process, though less specific than some systems, is that it considers duration of need and underlying disease in addition to the SOFA score acuity assessment. The basic triage process is outlined in Figure 4 and the exclusion criteria are described in
LETTER REPORT 87 Box 7, with additional supportive materials available in the original arti- cle. This process has informed most state guidance and other system guidance, including the VHA and other guidelines (Minnesota Depart- ment of Health, August 2008; VHA, 2008, 2009; The Utah Hospitals and Health Systems Association, January 2009; Colorado Department of Public Health and Environment, July 2009). If triage of mechanical ventilation/critical care becomes necessary assess existing critical care patients according to: â¢ SOFA score â¢ Expected duration of mechanical ventilation â¢ Any severe, life-limiting underlying disease states â¢ Other disease-specific factors Order patients from most sick to least sick and reassess daily or as conditions warrant New patient requires mechanical ventilation - Assess patient SOFA score, expected duration (rough) of mechanical ventilation, and underlying disease states or other contributing data/prognosticators (as above) Patient has exclusion criteria?a YES NO YES Triage out of critical care area Existing patients that no longer require critical care with appropriate transition (improved) or meet exclusion criteria (worsening)? a care for condition and NO reassess resource availability NO Treatment trial of ventilation if available for new patient, if no ventilator available contrast needs of new patient against existing âmost sickâ patient(s) - Compelling reason to reallocate from currently ventilated patients? YES Reallocate ventilator/resources to new patient, transition care for prior ventilated patient to available support given circumstances including appropriate palliative care FIGURE 4 Triage algorithm process. a Example exclusion criteria include severe, irreversible organ failure (CHF, liver, etc), severe neurologic compromise, extremely high or not improving SOFA scores, etc. SOURCE: Adapted from Devereaux et al. (2008b).
88 CRISIS STANDARDS OF CARE GUIDANCE BOX 7 Exclusion Criteria Prompting Possible Reallocation of Life Saving Interventions Sequential Organ Failure As- Severe, chronic disease with a short life sessment (SOFA) score criteria: expectancy patients excluded from critical A. Severe trauma care if risk of hospital mortality B. Severe burns on patient with any two of > 80% the following: A. SOFA > 15 i. Age > 60 yr B. SOFA > 5 for >5 d, and with ii. > 40% of total body surface area af- flat or rising trend fected C. > 6 organ failures iii. Inhalational injury C. Cardiac arrest i. Unwitnessed cardiac arrest ii. Witnessed cardiac arrest, not re- sponsive to electrical therapy (defi- brillation or pacing) iii. Recurrent cardiac arrest D. Severe baseline cognitive impairment E. Advanced untreatable neuromuscular disease F. Metastatic malignant disease G. Advanced and irreversible neurologic event or condition H. End-stage organ failure (for details see Devereaux et al., 2008b) I. Age > 85 yr (see Lieberman et al., 2009) J. Elective palliative surgery SOURCE: Adapted from Devereaux et al. (2008b) Critical care and ventilator allocation decision tools should be consistent with currently available evi- dence-based expert panel and national critical care guidelines, although modifications may be made to meet the specific needs of the state. Of note, ventilators may not be the only relevant limitation to me- chanical ventilation, as available staff, oxygen, and medication supply may not be able to support significantly more ventilators than the hospi- tal normally uses due to design and supply limitations, thus, wholesale purchase of ventilators may not obviate the issue. Finally, decision tools may be supplemented by event-specific information (e.g., mortality data
LETTER REPORT 89 during a pandemic for particular underlying disease states or age ranges) or by supplemental prognostic information (e.g., as discussed in pallia- tive care section). During an event such as a pandemic, federal guidance may be issued or epidemiologic information may be available that may affect state guidelines. As evidence improves in triage science, modifications to these rec- ommendations are likely. The state department of health or other appro- priate office must maintain an advisory panel that can consider and incorporate necessary updates to this information prior to and during events and provide feedback on or assist with crisis clinical guidance development to ensure that the best available evidence is used should this type of triage be required. These state entities are encouraged to work with localities to ensure that local/regional coordination is occurring in real-time. Recommendation 6: Ensure Consistency in Crisis Standards of Care Implementation State departments of health, and other relevant state agencies, in partnership with localities should ensure consistent implementation of crisis standards of care in response to a disaster event. These efforts should include: â¢ Using âclinical care committees,â âtriage teams,â and a state-level âdisaster medical advisory committee(s)â that will evaluate evi- dence-based, peer-reviewed critical care and other decision tools and recommend and im- plement decision- making algorithms to be used when specific life-sustaining resources become scarce. â¢ Providing palliative care services for all pa- tients, including provision of comfort, com- passion, and maintenance of dignity. â¢ Mobilizing mental health resources to help communitiesâand providers themselvesâto manage the effects of crisis standards of care by following a concept of operations devel- oped for disasters;
90 CRISIS STANDARDS OF CARE GUIDANCE â¢ Developing specific response measures for vulnerable populations and those with special medical needs, including pediatrics, geriat- rics, and persons with disabilities. â¢ Implementing robust situational awareness capabilities to allow for real-time information sharing across affected communities and with the âdisaster medical advisory committee.â CONCLUSION The potential tragedy wrought by catastrophic disaster, whether natu- rally occurring or due to intentional acts, should serve as a clarion call to political leadership, policy makers, disaster planners, and the community at large to carefully plan for the allocation of scarce resources efficiently and fairly. Under circumstances in which demand for care exceeds sup- ply, access to a broad continuum of healthcare resourcesâincluding those required for life-sustaining interventionâmay be curtailed. Disas- ter events may challenge the depth of human, materiel, and intellectual resources required to respond to them. A highly pathogenic pandemic, detonation of a nuclear weapon, destructive earthquake, or severe hurri- cane could each pose challenges to the delivery of health care beyond the âimaginable.â For this reason, it is imperative that as a nation, we con- sider our response to such events, ensuring that the processes we use to triage the delivery of care meet the highest ethical standards, and are based on the humanitarian imperative that âall possible steps should be taken to prevent or alleviate human suffering arising out ofâ¦calamity, and that civilians so affected have a right to protection and assistanceâ (The Sphere Project, 2004). In addition, while all populations remain vulnerable to catastrophic events particular populations remain more vulnerable than others. These populationsâas described in the commit- teeâs reportâshould be given particular attention to make sure their unique needs are considered in disaster planning and response efforts. As such, the Committee supports the efforts of the World Health Organiza- tion and similar agencies in affirming the importance of addressing health inequities and the social determinants of health because those most vulnerable in communities prior to a disaster are those most likely to be impacted adversely by the disaster itself (WHO, 2008).
LETTER REPORT 91 A number of overarching, guiding principles that were first eluci- dated in 2004 (AHRQ, 2005b) remain relevant in the discussion of this complex topic and were considered by the committee: â¢ Allocation of scarce resources is ultimately intended to preserve the functioning of the healthcare system, and to deliver the best care possible under emergency circumstances. â¢ Planning for the health and medical response to a catastrophic, mass casualty event must take a regional, systems approach, and involve a broad array of public and private community stake- holders. â¢ Adequate ethical and legal frameworks must be in place that pro- tect both the rights of patients and the rights of those providing care to patients, despite the austere conditions under which such care is being delivered. â¢ Active engagement of the public is essential; transparent com- munication of the complexities and challenges related to disaster responses must occur before, during, and after any catastrophic event to mitigate the potential for social disorganization and to promote community resilience. Crisis standards of care, as described in this report, will be required when the intent and ability to provide usual care is simply no longer pos- sible due to the circumstances. As acknowledged by the committee, some governments have made great strides in determining how to approach resource scarcity, but much work remains to be done. Indeed, the committee highlighted a number of areas worthy of fur- ther discussion, evaluation, and study. Some of these issues constitute real or perceived barriers that will make the implementation and opera- tionalization of crisis standards of care difficult to achieve. Some simply reflect the fact that the study of this area of disaster medicine remains an evolving pursuit requiring multidisciplinary participation. Nonetheless, the discussion around this topic has matured tremendously in the past few years. Despite the gaps that remain (see Table 8), the committee is greatly encouraged by the search for solutions that are taking place. In studying this issue, the committeeâs intent is to provide a frame- work that allows consistency in describing the key components required by any effort focused on standards of care in a disaster. It also intends that, by suggesting such uniformity, consistency will develop across ju- risdictions, regions, and states so that this guidance will be useful in con-
92 CRISIS STANDARDS OF CARE GUIDANCE tributing to a uniform national framework for responding to crisis in a fair, equitable, and transparent manner. TABLE 8 Impediments to Crisis Standards of Care Implementation Key Elements Gaps to Crisis Standards Implementation Ethical elements o Articulation of community values and preferences regarding allocation of scarce resources o Consultation and education for practitioners and com- munity about which actions are ethically justifiable during crisis standards, and which are not Community and provider o Absence of public and stakeholder discussion frame- engagement work o Absence of âclearinghouseâ repository for collected works o Financial impact of resource-sparing strategies o Financial commitments for community engage- ment/education processes o Incomplete, inconsistent regional partnership devel- opment Legal authority and o Inconsistent liability protections environment o Inconsistent application of scope of practice o Uncertainty about existing liability protections o Uncertain role of community âinformed consentâ Indicators and triggers o Limited situational awareness and real-time informa- tion exchange Clinical process and o Limited evidence base for select population groups operations (pediatrics, geriatrics) o Uncertain expectations for completion of diminished documentation o Uncertain process for deescalation from crisis care to conventional care (return to ânormalcyâ) o Uncertain processes for developing constructive after- action reports documenting crisis care responses o Uncertain strategy for using community-based assets of the health system (i.e., private practices, ambulatory care clinics) in managing a crisis surge response o Lack of meaningful/realistic exercise opportunity to evaluate scarce resource planning